Fluid removal device

ABSTRACT

A urine removal device includes a pouch with a proximal opening that provides access to an internal compartment of the pouch that is suitable to contain urine. A fluid diverter system is disposed inside of the pouch and extends from the proximal portion of the pouch, where it interfaces via an outlet conduit member to the environment outside of the pouch, to the distal end of the pouch where it draws in urine from the pouch. The pouch has at least one air port to allow air flow through the device to support suction that is applied inside of the pouch. The fluid diverter system has at least one conduit member configured to draw urine from the distal portion of the pouch up to the proximal end of the pouch, and into the outlet conduit member where it exits the fluid collection device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of Indian Patent Application Ser.No. 202011020467, filed May 14, 2020 (DAS Access Code: 9E9E), and toU.S. patent application Ser. No. 17/235,853 filed on Apr. 20, 2021, andtitled “FLUID REMOVAL DEVICE,” each of which is herein incorporated byreference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

BACKGROUND

Urine management systems are some of the most commonly used products ina variety of healthcare settings. Though typically associated withurinary incontinence in bedridden patients, the need extends further.For example, patients may require accurate monitoring of urine outputfor clinicians to evaluate their fluid-levels. Urine management systemsmay be used to reduce the burden of frequent urination in those who aresemi-ambulatory, or they may be used to reduce the risk of wounddevelopment by keeping the perineal and sacral skin dry. As the range ofclinical needs is broad, all care settings, from an ICU to the home, mayincorporate an assortment of urine management products.

One of the most common devices used for urine management in suchpatients is the indwelling urinary catheter, which may be designed forintermittent or extended use. These devices are low profile latex orsilicon tubes inserted through the urethra, all the way into thebladder, where they are anchored using a balloon, to continually drainurine into a collection bag or container. Since the invention of theFoley catheter nearly 100 years ago, the extended use of indwellingcatheters has continuously risen, until recently.

Placement of any product into the human body involves risks, especiallywhen the target anatomy is sensitive or sterile. In the case of urinarycatheters, the risk of patient harm during insertion and use issignificant enough to require trained care providers such as nurses orphysicians to perform the insertion, removal, and management of thedevices. Even when caution is taken, indwelling catheters can causesignificant impairment to urethral tissues during placement.Furthermore, maintaining catheter sterility is difficult. Patients oftenexperience pain and bleeding during insertion and are faced with thepossibility of bacteria being introduced into the bladder and renalsystem. Ultimately, there is a risk of patients developing injuries orurinary tract infections leading to subsequently bladder, kidney, orbloodstream infections.

To reduce these risks and improve clinical outcomes, care providers aretransitioning away from indwelling catheters and increasingly usingexternal management systems. These external management systems,especially in men, typically include a collection member to receiveurine and an anchoring mechanism, sometimes in the form of an adhesivefor securing the collection member in-place. Some of these systems aredesigned using soft and flexible materials for the collection member andinclude a drainage tube to remove accumulated fluid. Some external urinemanagement devices used in male patients anchor either on the tip of thepenile shaft or along the length of the shaft. In addition to a lack ofaccommodating anatomical size variations, itchiness, foreign bodysensation, or feeling of wetness are some of these systems'shortcomings.

Using soft and flexible materials for the collection member, as well asother components of such a system, such as a drainage tube that may beused in a genital or perineal region, is important for multiple reasons.One reason is that skin and tissues in the genital and perineal regionsare more sensitive than other areas of the body, meaning they are oftenat increased risk of injury. In clinical settings, it is not uncommonfor patients to experience skin maceration, dermatitis, and pressureinjuries. These complications may be due to tissue swelling exacerbatingskin weakness, from improper movement along with extended exposure tomoisture, or the use of devices/products in the area that become lodgedbetween the skin and another surface. Furthermore, soft and flexiblematerials allow patients to move with less discomfort, and more flexibleparts allow movement of a part of the product without the adhesive (usedto secure the collection member) becoming pulled on or stressed.

Drainage tubes used for these types of devices often have shortcomingssuch as kinking, which will either significantly decrease or completelyblock the flow of fluids through the lumen. As these tubes aresignificantly stiffer than the collection member, such as urinecollection bags, the interface between the drainage tubes and thecollection member can be another key point of weakness. For example,movement of the drainage tube causes kinking, bending, or twisting ofthe flexible tube at the connection point, resulting in reduced orblocked fluid flow.

Urine collection systems often irritate the skin and cause discomfort.When a portion of a management device is in contact with the human body,for example, in instances where the adhesive section is coupled to agenital area, the skin exposed to the internal aspect of the enclosedspace of the collection section will become moist. Urine received by thecollection section will either contact the skin directly or wet at leastpart of the internal surface of the flexible wall. Though the urine willbe drained from the collection section periodically or continually,small amounts of moisture will continue to cling to the surfaces thatwere exposed to urine. Furthermore, skin (e.g., on the penis) constantlyexudes small amounts of moisture via sweat, which over time, willaccumulate inside an enclosed area. Either of these mechanisms ofmoisture introduction can leave liquid droplets in direct contact withthe skin and increase the humidity within the enclosed space whilepotentially weakening the adhesive seal to the skin. Thisliquid/humidity creates a moist environment known to cause skinmaceration, which reduces the structural integrity of the skin andincreases the risk for skin damage such as dermatitis and pressure orfriction injuries.

Initial stages of maceration are typically identified via a whitenedappearance, wrinkling, and minor swelling. It is also known that changesin stratum corneum hydration, dermis hydration, transepidermal waterloss (TEWL), skin pH, and skin hardness can be used to evaluate skinintegrity. Healthy skin and macerated skin have measurable differencesin these physiological markers, as well as more nuanced markers such aserythema index (EI) and white index (WI). Removal of moisture from thecollection section and consequently from the skin reduces the risk thatthese markers deviate from healthy levels.

Currently available collection/protection devices that are external tothe body rely on an absorbent material, which is a relic of diapers andpads. The use of the absorbent materials may lead to wetness of theskin, bulkiness, and dislodgement or peeling-off of the device.Retaining absorbed urine may also lead to inefficient suction andreduced air flow. Furthermore, the multitude of components and complexmaterial layups can increase manufacturing complexity and cost.

As such, there is a need for a low-cost urine removal device thatenables urine to be conveniently and hygienically removed from theregion surrounding a male patient's external genitalia whilesimultaneously resisting kinking and folding, and that provides a dryinternal compartment with little or no pooled or residual urine.

SUMMARY OF THE DISCLOSURE

In some embodiments, a urine removal device comprises a flexible pouchdefining an internal compartment, the flexible pouch may have a proximalend and a distal end and an aperture disposed on an external surface,wherein the aperture is capable of receiving at least a part of a penis;at least one suction conduit member may be affixed to the flexible pouchand the suction conduit member may have a conduit shaft including afluid inlet, a fluid outlet, and a lumen connecting the fluid inlet tothe fluid outlet. The fluid inlet may be positioned within the internalcompartment of the pouch between the aperture and the distal end. Inembodiments, a first part of the conduit shaft is positioned between theaperture and the distal end and at least a second part of the conduitshaft is positioned between the aperture and the proximal end of thepouch.

The urine removal device may be configured such that the conduit shaftterminates within the internal compartment at a position between theaperture and the distal end of the flexible pouch.

In another embodiment, the second part of the conduit shaft extendsoutside of the internal compartment. Each conduit shaft may be a rigidor partially rigid shaft and may comprise one or more lumens. The urineremoval device may have one or more conduit shafts having a first fluidinlet within the internal compartment and a second fluid inlet withinthe internal compartment, wherein the first fluid inlet and second fluidinlet are positioned on opposite sides of the pouch. The first fluidinlet and the second fluid inlet may be positioned on opposite sides ofa longitudinal axis connecting the proximal and distal ends of thepouch. The urine removal device may also comprise a fold resistantfeature such as an accordion or bellows pleats on at least one suctionconduit member, wherein the fold resistant feature is configured toresist collapse of a lumen defined by the suction conduit member. Thefold resistant feature may be located on the section conduit member at alocation outside of the internal compartment and it may be locatedbetween the distal end of the pouch and the fluid outlet of the suctionconduit member.

In embodiments, the urine removal device may have one or more air inletspositioned between the aperture and the proximal end of the pouch andthe distance between the first fluid inlet and the second fluid inletmay be greater than the width of the aperture. The conduit shafts may berigid or partially rigid and configured to form a frame that separatesthe two opposing inner walls along the longitudinal axis connecting theproximal and distal ends of the pouch.

In some embodiments, the device for collecting and transporting urinecomprises a flexible pouch having an aperture configured to receive atleast a part of a penis, the flexible pouch having an interior surfacedefined by at least a first inner surface and an opposing second innersurface at least one suction conduit member affixed to the flexiblepouch. The conduit member may include a fluid inlet inside of the pouchnear the distal end of the pouch and a fluid outlet outside of thepouch. Furthermore, the pouch may comprise a plurality of flow directorsdisposed on at least a portion of the first or second inner surface ofthe pouch such that when the first inner surface and second innersurfaces are drawn together by vacuum suction, channels are createdtherebetween.

The flow directors may comprise grooves or ridges and the channels mayhave a depth of less than 1 mm in some embodiments. The grooves may berecessed into the first or second inner surface of the pouch and theflow directors may be substantially oriented parallel to an axisconnecting the proximal end and the distal end of the pouch. At interiorof the pouch may be non-absorbent and with enhanced hydrophobicproperties. In some embodiments, the aperture is located on a first walland the opposing wall includes at least one pleat oriented substantiallyparallel to a longitudinal axis connecting the proximal end to thedistal end of the pouch.

In some embodiments, the device for transporting urine comprises aflexible pouch having a first wall and an opposing second wall and anaperture through the first wall. The aperture may be configured toreceive at least a part of a penis. The device may include a framehaving a distal end inside of the pouch distal to the aperture and aproximal end outside of the pouch proximal to the proximal end of thepouch. The frame may comprise a lumen capable of transporting fluid fromthe inside of the pouch to the outside of the pouch when a vacuum isapplied to the lumen.

In some embodiments, the frame provides a structural support such thatthe bending stiffness of the overall device is substantially the same asthe bending stiffness of the structural support alone. The frame maycomprise two distal elongate members having a pair of openings at thedistal end of the pouch, wherein the distal elongate members converge toone proximal member at its proximal end. The distal elongate members maybe disposed at opposing sides of the pouch and they may be attached tothe pouch. The structural support may include a flexible joint proximalto the pouch to at least partially isolate the pouch from motion of theproximal end of the structural support to reduce tugging on the pouchand kinking near the interface between the pouch and the structuralsupport. The joint is a bellows section in some embodiments. An adhesivepatch may be attached to the flexible pouch and configured for fasteningthe flexible pouch to the patient's suprapubic region. The adhesivepatch may comprise a substrate having adhesive applied to at least onesurface. In some embodiments, the substrate is segmented into aplurality of interconnected tabs by one or more notches formed on thesubstrate and the interconnected tabs are not attached to the pouch.

For example, described herein are urine removal devices comprising: aflexible pouch having a front formed of first sheet and a back formed ofsecond sheet, wherein the first sheet and the second sheet are joinedtogether at the periphery of the pouch; an aperture through the back ofthe pouch, the aperture opening into an internal compartment within thepouch, wherein the aperture is configured to receive at least a part ofa penis; a suction conduit member extending from a proximal end regionof the pouch, the suction conduit member comprising a first conduitshaft extending along a right side of the periphery of the internalcompartment of the pouch and ending in a first fluid inlet at a distalend region of the right side of the pouch, and a second conduit shaftextending along a left side of the periphery of the internal compartmentof the pouch and ending in a second fluid inlet at a distal end regionof the left side of the pouch, wherein the suction conduit member has astiffness that prevents the first sheet and the second sheet fromwrinkling or folding in an axis transverse to a distal-to-proximal axis;and a flow directing spacer extending from the proximal end region tothe distal end region within the internal compartment of the pouch,wherein the flow directing spacer provides channels from the proximalend region to the distal end region within the internal compartment whensuction is applied within the internal compartment from the suctionconduit member.

The flow directing spacer may include a layer of polymeric fibersforming a plurality of channels. A majority(e.g., >50%, >55%, >60%, >65%, >70%, >75%, >80%, etc.) of the pluralityof channels may be oriented in a substantially proximal to distaldirection.

The flow directing spacer may include a hydrophobic non-wickingmaterial. The flow directing spacer may comprises an array of fibersattached to the first sheet, the second sheet, or both the first andsecond sheet.

The suction conduit member may extend outside of the proximal end of theinternal compartment and ends beyond the proximal end region of thepouch.

In any of these devices, each conduit shaft may be a rigid or partiallyrigid shaft. The conduit shaft may act as a support frame. For example,in any of these devices, the first and second conduit shafts may form aframe that separates two opposing inner walls of the pouch.

The first sheet and the second sheet may be formed of a polymericmaterial having a thickness 1 mm or less, and wherein the first conduitshaft and the second conduit shaft have an internal diameter of 0.5 mmor greater.

Any of these devices may include one or more longitudinal folds in thefirst sheet extending from the proximal end region to the distal endregion.

The conduit member may include a flexible joint proximal to the pouch toat least partially isolate the pouch from motion of a suction sourcetube.

The distance between the first fluid inlet and the second fluid inletmay be greater than a width of the aperture.

The flow directing spacer may includes grooves, ridges or grooves andridges having a channel depth of 1 mm or less.

Any of these devices may include a second flow directing spacer withinthe internal compartment.

Any of these device may include an adhesive patch attached to theflexible pouch, the adhesive patch configured for fastening the flexiblepouch to a patient's suprapubic region.

For example, described herein are urine removal device comprising: aflexible pouch having a front formed of first sheet and a back formed ofsecond sheet, wherein the first sheet and the second sheet are sealedtogether; an aperture through the back of the pouch, the apertureopening into an internal compartment within the pouch, wherein theaperture is configured to receive at least a part of a penis; a suctionconduit member extending from a proximal end region of the pouch, thesuction conduit member comprising at least one conduit shaft extendingalong the internal compartment of the pouch and ending in a fluid inletat a distal end region of the receptacle, wherein the suction conduitmember has a stiffness that prevents the first sheet and the secondsheet from wrinkling or folding; a flow directing spacer extendingwithin the internal compartment of the pouch, wherein the flow directingspacer provides channels from the proximal end region to the distal endregion within the internal compartment when suction is applied withinthe internal compartment from the suction conduit member; and anadhesive patch attached to the flexible receptacle, the adhesive patchconfigured for fastening said flexible receptacle to the patient'ssuprapubic region.

As mentioned, the flow directing spacer may comprise a layer ofpolymeric fibers forming a plurality of channels. The majority(e.g., >50%, >55%, >60%, >65%, >70%, >75%, etc.) of the plurality ofchannels may be oriented in a substantially proximal to distaldirection. The flow directing spacer may comprise a hydrophobicnon-wicking material. The flow directing spacer may comprise an array offibers attached to the first sheet, the second sheet, or both the firstand second sheet.

The suction conduit member may extend outside of the internalcompartment and ends beyond the proximal end region of the pouch. Theconduit member may include a flexible joint proximal to the pouch to atleast partially isolate the pouch from motion of a suction source tube.The first and second conduit shafts may form a frame that separates twoopposing inner walls of the pouch.

Any of these devices may also include one or more longitudinal folds inthe first sheet extending from the proximal end region to the distal endregion.

The distance between the first fluid inlet and the second fluid inletmay be greater than a width of the aperture.

The flow directing spacer may include grooves, ridges or grooves andridges having a channel depth of 1 mm or less.

For example, a urine removal device may include: a flexible pouch havinga front formed of a first sheet of liquid-impermeable material and aback formed of second sheet of liquid-impermeable material, wherein thefirst sheet and the second sheet are sealed together at a periphery ofthe pouch; an aperture through the back of the pouch, the apertureopening into an internal compartment within the pouch, wherein theaperture is configured to receive at least a part of a penis; a suctionconduit member extending from a proximal end region of the pouch, thesuction conduit member forming a frame comprising a first conduit shaftextending along a right side of the periphery of the internalcompartment of the pouch and ending in a fluid inlet at a distal endregion of the right side of the pouch, and a second conduit shaftextending along a left side of the periphery of the internal compartmentof the pouch and ending in a second fluid inlet at a distal end regionof the left side of the pouch, wherein the frame prevents the firstsheet and the second sheet from wrinkling or folding in an axistransverse to a distal-to-proximal axis of the device; and a flowdirecting spacer layer extending within the internal compartment of thepouch, wherein the flow directing spacer layer provides channels fromthe proximal end region to the distal end region within the internalcompartment when suction is applied within the internal compartment fromthe suction conduit member.

All of the methods and apparatuses described herein, in any combination,are herein contemplated and can be used to achieve the benefits asdescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the methods andapparatuses described herein will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,and the accompanying drawings of which:

FIGS. 1A and 1B, illustrate a perspective view and an exploded view ofan example embodiment of a urine removal device.

FIGS. 1C and 1D illustrate prior art urine removal devices in variousconfigurations.

FIGS. 1E and 1F illustrate a perspective view and a sectional view ofthe device in FIGS. 1A and 1B.

FIGS. 1G and 1H, illustrate a perspective view and an exploded view ofan example embodiment of a urine removal device.

FIG. 2A illustrates the flow pattern through a urine removal device.

FIGS. 2B-2C illustrate a prone patient wearing a urine removal deviceaccording to an example embodiment.

FIG. 2D illustrates a close-up view of the urine removal device of FIGS.2A-2B showing the attachment to the scrotum.

FIG. 3A illustrates a urine management system according to an exampleembodiment.

FIG. 3B illustrates a urine management system according to anotherexample embodiment.

FIG. 4A illustrates a perspective view of a urine removal device havingflow directors on a second wall according to an example embodiment.

FIG. 4B illustrates a perspective view of a urine removal device havingflow directors on a second wall and a first wall according to an exampleembodiment.

FIG. 4C illustrates a perspective view of a urine removal device havingflow directors on the middle wall according to an example embodiment.

FIG. 5A illustrates a perspective view of a pouch having oriented flowdirectors on an inner surface according to an example embodiment.

FIGS. 5B, 5C, and 5D illustrate fibers oriented on a surface at anglesof 0 deg., 15 deg., and 90 deg, respectively.

FIG. 5E illustrates a wall having a flow director layer.

FIG. 5F illustrates a wall having a flow director layer and an opposingwall in contact with the flow director layer.

FIGS. 6A and 6B illustrate a perspective view and an exploded view,respectively of a pouch having flow directors according to an exampleembodiment.

FIGS. 7A and 7B illustrate a perspective view and an exploded view,respectively of a pouch having flow directors according to an exampleembodiment.

FIGS. 8A and 8B illustrate a perspective view and an exploded view,respectively of a pouch having flow directors according to an exampleembodiment.

FIGS. 9A and 9B illustrate a perspective view and an exploded view,respectively of a pouch having flow directors according to an exampleembodiment.

FIGS. 10A and 10B illustrate a perspective view and an exploded view,respectively of a pouch having flow directors according to an exampleembodiment.

FIG. 11 illustrates a perspective view of a pouch having flow directorsaccording to an example embodiment.

FIG. 12A illustrates a perspective view of a pouch having flow directorsaccording to an example embodiment.

FIG. 12B illustrates a pouch embodiment having flow directors providedonly on specific portions inside the pouch.

FIG. 12C illustrates a pouch embodiment having flow directors providedonly on specific portions of internal walls of the pouch.

FIG. 13 illustrates the urine removal device oriented on a side showingurine temporarily pooling to one side of the device according to anexample embodiment.

FIG. 14 illustrates the air flow paths of a urine removal deviceaccording to an example embodiment.

FIG. 15 illustrates the air flow and urine flow paths of a urine removaldevice according to an example embodiment.

FIG. 16 illustrates the air flow and vapor flow paths of a urine removaldevice according to an example embodiment.

FIGS. 17A-17H illustrates a urine removal device and various types ofoptional valves for air ingress according to various exampleembodiments.

FIG. 18 illustrates the exploded view of a urine removal device having aone-way valve across the air ingress inlets and penis access apertureaccording to an example embodiment.

FIG. 19 illustrates a urine removal device having a deformed viewoverlaid on a perspective view according to an example embodiment.

FIG. 20 illustrates a perspective view of a urine removal device havingexternal conduit members according to an example embodiment.

FIG. 21 illustrates a perspective view of a urine removal device havinga having external conduit members with one or more inlets according toan example embodiment.

FIG. 22A illustrates a perspective view of a urine removal device havinga centrally located conduit member pair according to an exampleembodiment.

FIG. 22B illustrates a perspective view of a urine removal device havinga centrally located conduit member according to an example embodiment.

FIGS. 23A-23C illustrate a perspective view, a side view, and asectional view respectively of a urine removal device according toanother example embodiment.

FIG. 24 illustrates a bottom view of a urine removal device according toan example embodiment.

FIG. 25 illustrates a top view of a urine removal device according toanother example embodiment.

FIG. 26 illustrates a top view of a urine removal device according toanother example embodiment.

FIG. 27 illustrates a top view of a urine removal device according toanother example embodiment.

FIG. 28 illustrates a top view of a urine removal device according toanother example embodiment.

FIG. 29 illustrates a top view of a urine removal device according toanother example embodiment.

FIG. 30 illustrates a top view of a urine removal device according toanother example embodiment.

FIG. 31 illustrates a top view of a urine removal device according toanother example embodiment.

FIG. 32 illustrates a top view of a urine removal device according toanother example embodiment.

FIG. 33A illustrates a top view of a urine removal device having a flapover the pouch aperture acting as one-way valve according to an exampleembodiment.

FIG. 33B illustrates a top view of a urine removal device having a flapwith a gusset acting as one-way valve according to another exampleembodiment.

FIG. 34 illustrates a top view of a urine removal device having a pleator pleats on the pouch according to an example embodiment.

FIG. 35 illustrates a perspective view of a urine removal device havinga pouch with a domed shape according to an example embodiment.

FIG. 36 illustrates a perspective view of a urine removal device havinga urine sample port according to an example embodiment.

FIG. 37A illustrates a perspective view of an adhesive patch accordingto an example embodiment.

FIG. 37B illustrates a perspective view of the adhesive patch of FIG.37A showing various layers according to an example embodiment.

FIG. 38 illustrates a perspective view of an adhesive patch havingperforations according to another example embodiment.

FIG. 39 illustrates a perspective view of an adhesive patch havingperforations showing various layers according to another exampleembodiment.

FIG. 40 illustrates a perspective view of an adhesive patch havingperforations showing various layers according to another exampleembodiment.

FIGS. 41A-L illustrates various adhesive patch shapes according toexample embodiments.

FIG. 42 illustrates an adhesive patch shape according to another exampleembodiment.

FIG. 43 illustrates a plan view of the adhesive patch of FIG. 37A.

FIGS. 44-46 illustrate adhesive patch shapes according to other exampleembodiments.

FIG. 47 illustrates a device having a removable attachment for thepouch.

FIG. 48 illustrates a device having a removable attachment to aclothing.

FIG. 49 illustrates an embodiment of the urine removal device that hassuperabsorbent material within the pouch.

FIG. 50 illustrates the urine removal device oriented on a side showingurine temporarily pooling to one side of the device according to anexample embodiment.

FIG. 51 illustrates an embodiment of a section of a conduit having avalve, wherein the valve is in the open configuration.

FIG. 52A illustrates an embodiment of a section of a conduit having avalve, wherein the valve is in the closed configuration.

FIG. 52B shows another example of a section of conduit (in an apparatusas described herein) including a valve that may direct suction based onthe patient's posture. In FIG. 52B, the valve is a ball valve systemshown oriented on a side, wherein one valve is open and one is closed.

FIG. 52C shows another example of a section of conduit (in an apparatusas described herein) including a valve that may direct suction based onthe patient's posture. In FIG. 52C, the valve is a flap valve systemoriented on a side, wherein one valve is open and one is closed.

FIG. 53 illustrates a perspective view of an embodiment of a conduitsystem oriented horizontal or at an angle with respect to gravity.

FIG. 54 illustrates an embodiment of a conduit system orientedvertically with respect to gravity.

FIG. 55 is a flow chart illustrating the method of using a urine removaldevice according to an example embodiment.

DETAILED DESCRIPTION

Any of the methods (including user interfaces) described herein may beimplemented as software, hardware or firmware, and may be described as anon-transitory computer-readable storage medium storing a set ofinstructions capable of being executed by a processor (e.g., computer,tablet, smartphone, etc.), that when executed by the processor causesthe processor to control perform any of the steps, including but notlimited to: displaying, communicating with the user, analyzing,modifying parameters (including timing, frequency, intensity, etc.),determining, alerting, or the like.

The embodiments disclosed herein provide urine removal devices that aresuction-assisted, and enable urine to be conveniently and hygienicallyremoved from the region surrounding a male patient's external genitaliaarea.

For the purposes of this disclosure, the term “proximal” and “distal”are used with reference to the length of the urine removal device or thelength of a pouch that forms part of the urine removal device; that is,“proximal” denotes the first end of the device or pouch toward thesuprapubic region beyond where it engages with (or is positioned in thevicinity of) the base of the penis and “distal” denotes the opposedsecond end of the device or pouch toward the end where it residesbetween the legs of the patient. For the purposes of this disclosure,the terms “top” and “bottom” are used with reference to upper and lowersurfaces of the urine removal device or components thereof. That is,“top” denotes a surface or direction that is coincident with or in thedirection of the upper surface of the penis. In contrast, “bottom”denotes a surface or direction that is coincident with or in thedirection of the underside of the penis.

This disclosure describes urine removal devices that enable urinedischarged from a male patient's penis to be contained within a flexiblepouch and drawn out of the pouch and away from the genital region of thepatient by application of suction or negative pressure. The variousembodiments comprise a pouch having an aperture sized to permit a malepatient's penis. The pouch may be formed of one or more fluid-tight(liquid-impermeable) materials (for example, polyvinyl chloride,polypropylene, polyethylene, low-density polyethylene, high-densitypolyethylene, ethylene-vinyl acetate, polyvinylidene dichloride,biaxially oriented polypropylene, ethylene vinyl alcohol, natural rubberlatex, silicon rubber, polyurethane, coated synthetic or natural fabric,etc.) wherein the fluid-tight materials define an internal compartment.The fluid-tight materials form one or more external surfaces andinternal surfaces for the pouch. The aperture may be fixedly oradaptably sized to enable a male patient's penis to be insertedtherethrough and to be positioned within the internal compartment.Additionally, the pouch and aperture are configured such that uponinsertion of the patient's penis, at least a part of the penis (forexample, at least the tip of the penis or the meatus) and optionally,substantially the whole of the penis, is housed within the pouch in theregion between the aperture and the distal end of the pouch.

The urine removal device may include one or more fasteners or anchorsthat enable the penis to remain housed within the pouch unlessintentionally removed (or removed by application of force).

In addition, the urine removal device also includes one or more suctionconduit members. Each of the one or more suction conduit memberscomprise a conduit shaft having one or more fluid inlets, one or morefluid outlets, and a lumen connecting each of the inlet(s) andoutlet(s). The one or more fluid inlets of the suction conduit member(s)are positioned within or in fluid communication with the internalcompartment of the pouch. The one or more fluid outlets of the suctionconduit are configured for direct or indirect coupling with a suctionsource (for example, a vacuum supply). The one or more fluid inlets, oneor more fluid outlets and lumen(s) connecting the two, together defineone or more fluid passageways between the internal compartment and theone or more fluid outlet(s) (or a receptacle to which the one or morefluid outlet(s) are connected).

In some embodiments, the one or more such conduit members are configuredsuch that (i) the one or more fluid inlet (s) are positioned within orin fluid communication with the internal compartment of the pouch,between the aperture and the distal end of the pouch, and (ii) at leasta first part of the conduit shaft is positioned between the aperture andthe distal end of the pouch, and at least a second part of the conduitshaft is positioned between the aperture and the proximal end of thepouch. In an embodiment, a first end of the conduit shaft may terminatewithin the internal compartment of the pouch, at a position between theaperture and the distal end of the pouch. In an embodiment, a secondpart of the conduit shaft may extend out of the pouch and may terminateat a position either between the aperture and the proximal end of thepouch or may terminate at a position beyond the proximal end of thepouch in a direction that is opposed to the distal end of the pouch.

In an embodiment, the conduit shaft of the one or more conduit membersmay comprise a rigid, partially rigid, or partially flexible conduitshaft and may be positioned within or affixed to the pouch in a mannerthat provides a rigid or semi-rigid frame that reinforces the pouch.

In an embodiment, the one or more conduit members may be configured toprovide at least a first and a second fluid inlet within the pouch (orwithin the internal compartment of the pouch), wherein the first andsecond inlets are positioned on opposite sides of pouch (or of theinternal compartment of the pouch). In an embodiment, the first andsecond inlets are respectively positioned on opposite sides of alongitudinal axis connecting the proximal end and the distal end of thepouch (or of the internal compartment of the pouch).

In one or more embodiments, one or more of the conduit members areprovided with an occlusion resistant feature or an anti-kinking feature,comprising one or more accordion pleats or bellows folds at one or moreregions of the conduit members. The accordion pleats or bellows foldsenable the conduit members to resist being kinked, twisted, folded, orcollapsed, which maintains the patency of the lumen defined between thefluid inlet(s) and fluid outlet(s) of the conduit member(s) and preventsblockage of the fluid passageway between the fluid inlet(s) and fluidoutlet(s). In an embodiment, the occlusion resistant feature oranti-kinking feature may be on the one or more on the conduit shaft(s)of the conduit members at a location outside of the internal compartmentof the pouch and may be located between the distal end of the pouch anda fluid outlet of the conduit member.

The pouch is additionally provided with one or more air inlets (otherthan the aperture) that enable air to be drawn into the pouch. In anembodiment, the one or more air inlets are positioned relatively closerto the proximal end of the pouch and relatively further from the distalend of the pouch. In a specific embodiment, the one or more air inletsare positioned between the aperture and the proximal end of the pouch.

When the urine removal device is disposed on a subject's penis (i.e.,when at least some of the penis is housed within the internalcompartment of the pouch), urine released from the meatus flows into thepouch and is drawn (by the application of suction) into the fluidinlet(s) and through the lumen(s) connecting the fluid inlet(s) and theone or more fluid outlet(s) of the conduit member(s), and out of the oneor more fluid outlet(s) (for example into a receptacle to which the oneor more fluid outlet(s) are connected). As a result of the applicationof suction through the conduit member(s), urine released or pooled intothe pouch is readily and hygienically removed from the pouch and thevicinity of the patient's penis. Additionally, as a result of theapplication of suction through the conduit member(s), negative pressureis created within the pouch, and air is drawn into the pouch through theone or more air inlets for as long as suction is applied. The air flowthus generated additionally serves to draw urine away from the tip ofthe penis and in the direction of the fluid inlet(s). Maintaining thesuction and consequent air flow results in urine within the pouch beingquickly drawn out and resultant dehumidification/drying of the pouch.

Additionally, in the configuration where the one or more conduit membersare configured to provide at least a first and a second fluid inletwithin the pouch, and the first and second inlets are respectivelypositioned on opposite sides of a longitudinal axis connecting theproximal end and the distal end of the pouch, it has been found that theurine removal device proves to work while tilted. When a patient islying on a side, the pouch tends to be aligned such that one side ishigher than an opposite side, and as a result, urine released from thepenis will pool on or at the lower internal side wall. Having multiplefluid inlets distributed on opposite sides of the longitudinal axisensures that, regardless of which side of the pouch is positioned lower,there is at least one fluid inlet that is in the vicinity of the poolingurine and through which the urine can be drawn out of the pouch.

In an embodiment, the distance between the first and second fluid inletspositioned on opposite sides of the longitudinal axis is greater thanthe diameter or width of the aperture provided on the pouch. In anotherembodiment, the distance between the first and second fluid inletspositioned on opposite sides of the longitudinal axis is greater than(i) a maximum width of the aperture in a direction perpendicular to alongitudinal axis connecting the proximal end and distal end of thepouch, or (ii) the maximum width of the aperture (as measured on an axisthat is perpendicular to the longitudinal axis and that passes throughthe aperture).

Specific embodiments of the invention are now described in connectionwith the accompanying figures in which like reference characters referto the same parts throughout the different views. The drawings are notnecessarily to scale, emphasis instead being placed upon illustratingembodiments of the present invention.

Referring to FIG. 1A-1D, a urine removal device 1 is shown according toan example embodiment. FIG. 1A shows a perspective view of the device 1and FIG. 1B shows another perspective view of the device 1 exploded toshow the interaction of the components more clearly, while FIG. 1Cprovides a perspective view from which a cross-sectional view (FIG. 1D)is taken to illustrate the interaction of the pouch walls with theconduit members.

The device 1, as shown in FIG. 1A, includes a pouch 2 having a firstwall 4 and a second wall 6. It would be understood that in otherembodiments, the pouch 2 may equally be formed of a single continuousside wall having two opposite surfaces, where one of the two oppositesurfaces forms an external sidewall and the other of the two oppositesurfaces forms an internal sidewall. The second wall 6 or first wall 4may have air ports 30 to allow ambient air to be drawn into the pouch 2to facilitate air flow through the pouch. In the illustrated embodiment,the second wall 6 and first wall 4 are attached to each other at leastaround most of their periphery such that they form an internalcompartment between them for housing the penis and the urine that itdischarges. One or more conduit members may be at least partiallylocated within the pouch 2 to facilitate the transfer of urine out ofthe pouch. For example, FIG. 1A shows a first conduit member 18 and asecond conduit member 22 as hidden lines, extending from the proximalend 16 of the pouch 2 to near the distal end 20. While the Figuresillustrate conduit members 18 and 22 as two separate members, in certainembodiments, the two could be integrated within a single shaped conduitmember (for example, a u-shaped, c-shaped, v-shaped, or wishbone-shapedconduit member having two ends each lying on opposite sides of alongitudinal axis that connects the proximal and distal ends of thepouch 2. As shown in the Figures, each of conduit members 18 and 22respectively comprise a conduit shaft 14 and 11, respectively, havingfluid inlet openings 15 and 12 and fluid outlet openings 17 and 13,wherein each conduit shaft 14 and 11 defines an internal lumenconnecting the respective fluid inlet openings 15, 12 and fluid outletopenings 17 and 13 such that fluid can be drawn from fluid inletopenings 15, 12 through the internal lumen of the conduit member 18 and22 and out of fluid outlet openings 17 and 13.

As illustrated in FIGS. 1A to 1C, the one or more such conduit membersmay be configured such that (i) the one or more fluid inlets 15 and 12are positioned within the internal compartment of the pouch 2, betweenthe aperture 3 and the distal end 20 of the pouch, and (ii) at least afirst part of the conduit shaft(s) 14 and 11 is positioned between theaperture 3 and the distal end 20 of the pouch 2, and at least a secondpart of the conduit shaft(s) 14 and 11 is positioned between theaperture 3 and the proximal end 16 of the pouch 2. In an embodiment, afirst end of the conduit shaft(s) 14 and 11 may terminate within theinternal compartment of the pouch 2, at a position between the aperture3 and the distal end 20 of the pouch 2. In an embodiment, a second endof the conduit shaft(s) 14 and 11 may extend out of the pouch 2 and mayterminate at a position either between the aperture 3 and the proximalend 16 of the pouch 2, or may terminate at a position beyond theproximal end 16 of the pouch 2 in a direction that is opposed to thedistal end 20 of the pouch 2. As further described below, where theconduit shaft(s) terminate, they may be in fluid communication with theoutside of the pouch 2 through another conduit (e.g., suction sourcetube 24).

The suction source tube 24 may reside at the proximal end 16 of thepouch 2 for connecting to a vacuum supply. The suction source tube 24connects to the fluid outlet openings 17 and 13 of the first conduitmember 18 and the second conduit member 22 to draw fluid (urine) fromthe distal portion 20 of the pouch 2 and out of the pouch 2 so that theinterior internal compartment may be kept relatively dry and to preventurine stasis and pooling. A fastener or anchor such as an adhesive patch8 may be attached to an external surface of the second wall 6 to securethe pouch 2 to the patient's penis, abdomen, scrotum, or suprapubicregion. The adhesive patch 8 may be a single layer, or it may becomprised of several layers, as described in more detail below.

The device 1 is shown in an exploded view in FIG. 1B to furtherillustrate the relationship of the components and features. The firstand second conduit members 18 and 22 (or more specifically, the firstand second fluid outlets 17 and 13 may connect to an adapter 32, whichconnects both conduit members 18 and 22 to the suction source tube 24.One skilled in the art would recognize that adapter 32 may be a varietyof devices to serve the purpose of connecting multiple tubes to one ormore outlets; examples include a Y-connector, T-connector, or amanifold. Alternatively, the first and second conduit members 18 and 22may be made integral to the suction source tube 24 so that a connectoris not required. The conduit members 18 and 22, the adapter 32, and thedistal end of the suction source tube 24 are located between the firstwall 4 and second wall 6 and may be retained by one or more conduitmember retainers 26 (shown as hidden lines in FIG. 1A and furtherdescribed below).

The one or more conduit members 18 and 22 may comprise conduit shafts 14and 11 that may be rigid, partially rigid, or partially flexible, andare positioned within, or affixed, to the pouch 2 in a manner thatprovides a rigid or semi-rigid frame to stiffen the device 1.Furthermore, in embodiments, the frame optionally separates opposingwalls 4 and 6 of the pouch 2 from each other. The frame formed by theone or more conduit members 18 and 22 enables the pouch 2 to resistdeformation or kinking in a manner that could occlude fluid flow betweenregions of the pouch 2. The structural frame may also include thesuction source tube 24 and the adapter 32 that connects the suctionsource tube 24 to the conduit members 18 and 22. In this sense, thestructural frame extends from within the pouch 2 to outside of the pouchso that the stiffness of the device 1 is increased, which may reducedeformation of the pouch that may lead to a vacuum lock as describedbelow.

There are instances where the pouch may deform in such a way thatprevents suction to be effective throughout the pouch. For example, apouch 7 in a deformed state is illustrated in FIG. 1C where a bend 7 bin the pouch 7 a of the device 7 results in a vacuum lock or occlusionof fluid flow because the inlet 7 c to the suction conduit 7 d is distalto the bend 7 b; this arrangement may result in totally or partiallyisolating the upper portion of the pouch 7 a from the applied suction.In another example, FIG. 1D shows the device 7 having a bend 7 e near anend of the pouch 7 a wherein the inlet 7 c of the suction conduit 7 dbutts up against the pouch 7 a and becomes occluded, which results in adecrease in fluid flow to the suction tube. This may happen, forexample, when a patient or operator moves the suction conduit 7 d or anylonger tubing attached to it—the motion may locally fold the bag andblock the inlet 7 c, thus reducing suction. A wrinkled pouch may lead toa decrease in fluid flow or in creation of isolated compartments withinthe pouch that may not be exposed to suction. In the absence of anyspacing features, the internal walls of the pouch may cling together dueto application of negative pressure from the suction conduit within thepouch resulting in a vacuum lock or occlusion of fluid flow or in thecreation of isolated compartments within the pouch. Similar to FIG. 1D,the inlet of the suction conduit may become occluded by the pouch whenit collapses due to vacuum. These problems may be mitigated by thestructural support provided by the conduits or other flow directingfeatures described in embodiments disclosed herein. For example, havinga structural support that spans from within the pouch 2 to the outsideof the pouch, as shown in FIGS. 1A-1B (among others) prevents kinkingwhere the suction source tube 24 meets the pouch 2, thus preventing thedeformation illustrated in FIG. 1D.

Now with reference to FIGS. 1E and 1F, the pouch 2 may have one or moreconduit member retainers 26 to hold the conduit members 18 and 22 inplace. The conduit member retainers 26 may be created by joining thefirst wall 4 to the second wall 6 or by joining the conduit with firstwall 4 or the second wall 6 (or both) in discrete or continuous spots orlines next to each conduit member 18 and 22 to create a barrier thatconstrains the conduit member(s). One skilled in the art will recognizethat there are many other alternative methods to create the barrier,such as bonding a small spacer between the walls adjacent to the conduitmembers, or forming one or both walls in a manner to create a featureprotruding into the space between the walls deep enough to retain theconduit members. The second wall 6 and first wall 4 may be joined by anymethod for connecting polymers such as, for example, bonding with anadhesive, solvent bonding, or heat staking (thermal bonding). In otherembodiments, the conduit members may be directly joined to the firstwall 4 or the second wall 6, or both, using a suitable joining process.In some embodiments, the conduit members may be located external to thepouch except at the distal tip of each conduit member where they enterthe pouch or be in fluid communication with the pouch to provide suctionin the distal portion of the pouch. The conduit member retainers 26 holdconduit members in place against the pouch 2 to prevent the undesiredmovement of the pouch walls causing the pouch 2 to assume a folded orkinked configuration, resulting in occlusion of the fluid inlet openings15 and 12 of the conduit members 18 and 22 or in blockage of a fluidflow path between a region in which urine has accumulated within pouch 2and one or more of the fluid inlet openings 15 and 12.

As shown in the device 10 of FIGS. 1G and 1H, an occlusion resistantfeature or an anti-kinking feature may be provided on suction sourcetube 24, or for that matter on any one or more of the conduit members 18and 22, to enable the suction source tube 24 or any of conduit members18 and 22 to resist being kinked, twisted, folded or collapsed, thusmaintaining the patency of the lumen defined between the fluid inlet(s)and fluid outlet(s) of the conduit member(s) which prevents blockage ofthe fluid passageway between the fluid inlet(s) and fluid outlet(s). Asshown in FIGS. 1G and 1H, the anti-kinking feature may comprise aconduit segment (or a tube segment) 242 comprising one or more accordionpleats or bellows folds. The pleated or folded conduit segment 242enables the suction source tube 24 or any of conduit members 18 and 22on which it is provided to resist being kinked, twisted, folded, orcollapsed. In an embodiment, the conduit segment 242 is provided either(i) at a junction between suction source tube 24 and conduit members 18and 22, or (ii) proximal to the junction between suction source tube 24and conduit members 18 and 22, toward the suction source. In anembodiment, the anti-kinking feature may be provided at a locationoutside of the pouch 2 and may be located between the distal end of thepouch 2 and a fluid outlet of the suction source tube 24.

One skilled in the art will recognize that there are manyimplementations of a conduit member that serve to provide access to theinside of the pouch. For example, in some embodiments, the conduitmember or channel may be integral to the pouch so that the stiffness ofthe joint formed by the conduit member and the pouch is matched toprevent a pinch point where a tube, being stiffer, may otherwise creaseat the relatively more flexible pouch. In other embodiments, the pouchmay be reinforced in the area where the conduit members 18 and 22 orsuction source tube 24 attaches, or the suction source tube 24 mayprotrude far enough into the pouch to reduce the likelihood of a pinchpoint at the joint.

Further considering FIG. 1B, the adhesive patch 8 may be comprised ofsingle or multiple layers and includes a substrate layer 9 having anouter surface 9 a, which is attached to an external surface of secondwall 6 of the pouch 2. The inner surface 6 b of the second wall 6 may bebare, as shown, or it may have an attached or integrated laminate or asurface treatment or a surface texture to accentuate urine flow towardsthe distal end 20 of the pouch 2 as described below. Likewise, the innersurface (not shown) of the first wall 4 may have a laminate attached, orit may have a surface treatment or a surface texture to improve fluidflow. The second wall 6 of the pouch 2 has an aperture 3 thatapproximately aligns with an aperture 43 in the adhesive patch 8. Theaperture 3 and the aperture 43 provide access for the penis to enterinto the pouch 2. The inner surfaces 6 b and 4 b (not shown) ofrespective second wall 6 and first wall 4 may have coatings or featuresto direct air and liquid flow, as described in more detail below, or maybe bare or untreated as shown. In a particular embodiment, fluid inletopenings 15 and 12 are positioned within the same internal compartmentwithin which the penis discharges urine, without any intermediate layerseparating said fluid inlet openings 15 and 12 from the internalcompartment.

FIG. 1F illustrates the interface between the conduit members and thepouch walls in an embodiment; the cross-section A-A taken from FIG. 1Eis made through the conduit member retainers 26 to illustrate how thetubes are captured. With reference to the cross-sectional view A-A, thefirst conduit member 18 is enveloped on one side by the first wall 4 andon the opposite side by the first wall 4, and the second wall 6 and thefirst wall 4 are joined on each side of the conduit member 18. Theconduit member retainer 26 represents the location where the second wall6 and first wall 4 are joined adjacent to the conduit member 18, and thepouch seam 27 is where the first wall 4 and second wall 6 are joinedoutside of the conduit member 18. Thus, the conduit member 18 is captivesuch that it stays in the location generally adjacent to the pouch seam27, which adds stability and stiffness to the device 1, as discussed infurther detail below. The same arrangement exists on the opposite sidewith respect to the second conduit member 22. In between the conduitmember retainers 26, the first wall 4 and second wall 6 arepredominantly not attached so that they form the interior internalcompartment 19 of the pouch 2.

As illustrated in FIGS. 1E to 1F, the conduit members 18 and 22 may beconfigured to provide at least a first fluid inlet 15 and a second fluidinlet 12 within the pouch 2, wherein the first and second inlets 15 and12 are respectively positioned on opposite sides of pouch 2, and moreparticularly are respectively positioned on opposite sides of alongitudinal axis ‘1’ that connects the proximal end 16 and the distalend 20 of the pouch 2. When a patient is lying on a side, the pouch maytip over and tends to be aligned such that one side or one internalsidewall of the pouch that connects the proximal and distal ends ishigher than an opposite side or opposite internal side wall, and as aresult, urine discharged from the penis will pool on or at the lowerinternal side. Having multiple fluid inlets (e.g. fluid inlets 12 and15) distributed on opposite sides of the longitudinal axis ‘1’ ensuresthat regardless of which side of the pouch is positioned lower, there isat least one fluid inlet that is in the vicinity of the pooling urineand through which the urine can be drawn out of the pouch.

In an embodiment, the distance between the first and second fluid inlets15 and 12 positioned on opposite sides of the longitudinal axis ‘1’ isgreater than the diameter or width of the aperture 3 provided on thepouch 2. In another embodiment, the distance between the first andsecond fluid inlets 15 positioned on opposite sides of the longitudinalaxis 1 is greater than the maximum width of said aperture 3 measured onany axis that is perpendicular to the longitudinal axis ‘1,’ and thatpasses through the aperture 3.

In an embodiment of the urine removal device 1, a skin-friendly materialdisposed on one or more external surfaces of pouch 2, for improvedpatient feel.

The urine removal device is shown in an exemplary patient use scenarioin FIGS. 2A-2D. In the above arrangements, the suction source tube 24,which is attached to a vacuum source, provides suction pressure to theconduit members 18 and 22, which extract urine from the distal end 20 ofthe pouch 2. For example, FIG. 2A illustrates the manner in which urinereleased into pouch 2 of the urine removal device (by a patient's peniswhen it is positioned within pouch 2 through the aperture 3) is drawn bynegative pressure applied by a vacuum source, from pouch 2 into conduitmembers 18 and 22 and out of suction source tube 24. To facilitatecontinued suction and the flow of urine, one or more air ports 30 may belocated on the pouch 2 to allow air into the pouch 2 to prevent a vacuumlock condition which may reduce or stop the flow. As used herein, theterm “vacuum lock” refers to a condition wherein when vacuum is appliedto a cavity with flexible walls, the walls may be sucked into contact,thus restricting or preventing a liquid or gas from flowing through thecavity because the approximated walls reduce or eliminate viable flowpaths. One skilled in the art will recognize that additional oralternative air ports may be located at alternative locations to providean air conduit into the interior of the pouch.

As illustrated in FIG. 2B, the patient is shown laying supine with theurine removal device 1 attached. In this embodiment, the device 1attaches around the penis such that the suction source tube 24 residesnear the lower abdomen rather than between the legs, as is the case withcommonly used urinary incontinence devices. This arrangement addressesthe problems of the tube contacting the patient's legs and theassociated discomfort, pressure point injuries, kinking, leakage, andtangling because no hoses or tubes are residing on or between thethighs. FIG. 2C shows a similar view of the pelvic area however showingthe penis 34 residing inside of the pouch 2 near the proximal end 16 ofthe device 1.

Now with reference to FIG. 2D, which illustrates how, in someembodiments, the adhesive patch 8 may attach to the scrotum 36. Thisview shows the pouch 2 folded up only for the purpose of displaying theouter surface 9 a of the substrate layer 9, which attaches to the outersurface 6 a of the second wall 6 of the pouch 2. The attachment betweenthe outer surface 6 a and the outer surface 9 a may span the entireouter surface 9 a or only part of the outer surface 9 a so that in someembodiments, the pouch 2 may articulate somewhat independently of theadhesive patch 8. The inner layer (not shown) of the adhesive patch 8contacts the body and has an adhesive that allows it to adhere to thescrotum 36, even overtop hair follicles, skin folds, wrinkles, as wellas the sweat and moisture that may precipitate in the scrotum and groinarea, while being painless to remove from the scrotum 36. One skilled inthe art would recognize that there are many appropriate adhesivesincluding porous and nonporous silicones. Adhesive patch embodiments aredescribed below in the section titled ‘BODY ATTACHMENT’ below.

Vacuum-assisted urine collection systems typically have a suction tubethat runs from the outlet tubing, across the patient, to an externalcollection system. Conventional effluent collection systems for urineand stool have drainage tubing connection points between the legs, whichmay lead to leg-entanglement or obstruction from a limb or bedding, andis a known risk factor pressure point injuries and skin breakdown.Placing the access point in the suprapubic region and draping the tubingover the pelvis, hips, or midsection reduces these risks. FIG. 3Aillustrates a simplified schematic of a urine management system 37 forcollecting urine according to an example embodiment. As shown in FIG.3A, the system 37 includes the urine removal device 1 described above, adrain tube 38, a urine collection reservoir 40, a vacuum source tube 42,and a vacuum source 44.

The proximal end 16 of the urine removal device 1 is coupled to thedrain tube 38, which interfaces with the suction source tube 24 at afirst end 38 a of the drain tube 38. Any type of connector know by thosein the art may be used to connect the drain tube 38 to the suctionsource tube 24 while being within the scope of this disclosure; examplesinclude a Luer lock, thread, step, or other connector with or withoutone-way valve. Alternatively, the drain tube and the suction source tube24 may be one contiguous tube. The drain tube 38 may be a flexible tubethat can be manipulated by the practitioner and draped over or under thearm. Notably, the drain tube 38 attaches to the proximal end 16 of thedevice 1 such that it passes over the abdomen rather than between thelegs, where it is directed away from the body (e.g., off of the bed).This arrangement reduces entanglement with the legs and bed sheetscovering the legs and reduces accidental pulling of the drain tube 38from the suction source tube 24, thus preventing leakage when thepatient moves and turns in bed while preventing the discomfort of havinga tube winding amongst the legs. Having the drain tube 38 accessibleacross the middle of the body also provides easy access forpractitioners as they do not have to search for the drain tube 38between or underneath the legs.

The second end 38 b of the drain tube 38 is coupled to the urinecollection reservoir 40 which contains the urine from the drain tube 38.The urine collection reservoir 40 may be a urine collection bag, such asa leg bag or drainage bag, or another container such as a bottle, bucketor canister. The urine collection reservoir 40 may be a sealed device toreduce spillage; in some examples, it may be a disposable unit or it maybe a reusable unit that may be washable and/or sterilizable.

The urine collection reservoir connects to the vacuum source 44, whichapplies vacuum pressure to the vacuum source tube 42 and drain tube 38to assist in directing the urine from the suction source tube 24 to theurine collection reservoir 40. The vacuum source 44 may be a wall vacuumintegrated into a room of a medical facility to its central vacuumgeneration unit. In other examples, the vacuum source 44 can beintegrated with the patient's bed. In general, the urine collectionreservoir 40 may include a filter or valve system to prevent urine fromtransiting up the vacuum source tube and into the vacuum source 44. Thesystem 37 may also include a clip or valve for shutting off the supplyof urine from the drain tube 38 so that the urine collection reservoir40 may be emptied or changed.

Another embodiment of a urine management system 46 is illustrated inFIG. 3B; this embodiment differs from the urine management system 37 ofFIG. 3A in that the urine collection reservoir 50 has an onboard vacuumgenerating unit 48 to create vacuum independently of any hospital orfacility vacuum source. Thus, the second end 38 b of the drain tube 38connects into the collection reservoir 50, which has a vacuum source orvacuum generating unit 48 to draw urine into the collection reservoir50. Since there is no requirement for hospital/facility wall suction,this urine management system 46 offers more flexibility for use in thehome, hospice, or long-term care, for example. Additionally, in someembodiments, the onboard vacuum generating unit 48 may be powered byonboard batteries, obviating the need for a power plug and a wall powersource, thus providing more flexibility for use in different locationsand settings such as a mobile platform, mobile bed, or wheelchair. Theurine collection reservoir 50 may be fully reusable, or disposable, orin other embodiments, the urine collection portion may be disposablewhile the onboard vacuum generating unit 48 may be disposable orreusable.

Fluid & Moisture Removal

The ability of the system to effectively remove fluid & moisture isinfluenced by at least three aspects of the device design: the pouch,the fluid flow system, and the structural support system, all of whichmay be coupled. More detailed descriptions of each aspect are describedbelow.

Pouch

The pouch is defined by a substantially flexible and liquid impermeableform with a fluid receiving area between one or more walls (for examplea first wall and a second wall). The form creates an essentiallyenclosed space, either independently or when in communication with thebody, and has a patient-side (second wall) and an environment-side(first wall). The form is configured to be liquid impermeable andessentially enclosed to provide a receiving area to receive urine and atleast temporarily hold urine within the enclosed space. The impermeableform may be constructed of multiple layers, either coupled or uncoupled,and the entire construction of layers, whether single or multiple, maybe described as a flexible wall.

The outermost aspect of the flexible wall is composed of a liquidimpermeable material to ensure any effluents received are temporarilycontained within the form. The flexible wall is fashioned such that theinternal aspect of the enclosed space will not allow the flexible formto collapse in a way that can fully or partially block fluidcommunication between the proximal and distal ends of the space. Fluidcommunication requires some viable flow channels between the surfacesand may be achieved with a variety of constructions. Furthermore, theflexible wall can be fabricated to reduce or eliminate the occurrence ofa vacuum lock. In these instances, a low pressure pulls a surfaceagainst either the source itself in such a way to prevent fluidcommunication or pulls two or more surfaces against each other in amanner that creates a separate chamber surrounding the source resultingin a chamber that is no longer in fluid communication with the originalenclosed space.

As described in more detail herein, example embodiments of the pouchillustrate features for maintaining fluid communication between opposingends of the liquid impermeable form such as by way of nonlimitingexample: the addition of physical separation components running from oneend of the form to another end or through a section of the form, theinclusion of material within the form involving physical characteristicssuch as webbing or mesh, texturing of the form internal or externalsurfaces, creating undulations or texture-like features by altering theform's cross-sectional shape, or utilizing a material and design thatprovides a shape whose structure is stronger than the forces that wouldcollapse the form. One skilled in the art would recognize that there aremany other ways to maintain fluid communication inside the pouch andsuch designs are within the spirit of the embodiments disclosed hereinand contemplated in this disclosure.

“Flow directors,” as used herein refers to features on or within thepouch that provide for fluid flow channels or pathways to provide forurine flow within and out of the pouch, for example when the urineremoval device is exposed to applied vacuum. The features may be at asmall scale such as where capillary forces govern, or larger features,or combinations of small and large features, with for example, surfacetreatments that may affect hydrophobicity. The flow directors providegrooves (channels) when the pouch walls come together under vacuum, thuspreventing vacuum lock between the layers of the pouch. In someembodiments the flow directors are oriented in the direction of thedesired flow but in other embodiments flow directors may be at otherangles or randomly arranged. The following figures and descriptionsprovide non-limiting examples of flow directors.

Flow directors can be formed from the same base material as that of thepouch layer or of different material which may be then bonded with thepouch layer using the process of heat or other method of lamination,gluing, chemical bonding, printing, or any other similar processespracticed in the art. When flow directors are made of same base materialas that of the pouch layer, they can be formed during the primaryextrusion of the pouch layer or later using a secondary process such asembossing, chemical etching, laser etching, grooving, engraving,carving, imprinting, etc. The flow directors may be left uncoated orcoated with chemicals such as Teflon, PTFE, etc. or nanoparticles toimprove hydrophobicity. The size of flow directors can range from fewnanometers, as it would be in case of etching, to few microns as itwould be in case of embossing, to tens of hundreds of microns as itwould be in case of the lamination processes. The flow directors can belinear, such that they substantially align with the axis connecting theproximal and distal end of the pouch, wavy, diamond, honeycomb or anyother similar shape, or completely random, that may be interconnectedwith one another in such a way that the gross effect attained by theflow directors is in the desired direction of flow. The flow directorscan be on the entire surface or some part of the inner surface of one orboth pouch layers.

FIGS. 4A-4D show pouch embodiments with differing layups that includesurfaces with flow directors. With reference to FIG. 4A, an embodimentof a pouch 52 is shown which may have conduit member retainers 58, airports 60, and a first wall 55, through which the air ports 60 pass, anda second wall 56 connected to the first wall 55. In embodiments, theinner surface 55 b of the first wall 55 may be substantially bare, asshown, that is, untreated and unlaminated, while the inner surface 56 bof the second wall 56 may have flow directors which may, for example, bemolded, hot-rolled, deposited, bonded, spray-coated, etched, formed orembossed in the inner surface 56 b or attached as a laminate on innersurface 56 b. Inner surface 56 b is shown shaded in the figures toillustrate that it has flow directors.

With reference to FIG. 4B, an embodiment of a pouch 62 is shown whichmay have conduit member retainers 68, air ports 70, and a first wall 65,through which the air ports 70 pass; the first wall 65 is connected to asecond wall 66. This embodiment differs from that in FIG. 4A in thatboth the inner surface 66 b of the second wall 66 and the inner surface65 b of the first wall 65 may have flow directors which may be molded,hot-rolled, deposited, bonded, spray-coated, etched, formed or embossedin the inner surfaces 65 b and 66 b, or attached as a laminate on innersurface 65 b or 66 b, for example. Inner surface 66 b and inner surface65 b are shown shaded in the figures to illustrate that each has flowdirectors.

Referring now to FIG. 4C, another embodiment of a pouch 72 is shownwhich may have conduit member retainers 78, air ports 80, and a firstwall 75, through which the air ports 80 pass; the first wall 75 isconnected to a second wall 76. This embodiment differs from that in FIG.4B in that both the inner surface 76 b of the second wall 76 and theinner surface 75 b of the first wall 75 may be bare, while flowdirectors may be either molded, hot-rolled, deposited, bonded,spray-coated, etched, formed or embossed or attached as a laminate onone or both sides of the middle layer 79 which is disposed between thesecond wall 76 and the first wall 75. Furthermore, the middle layer 79resides captive between the first wall 75 and the second wall 76 and itmay be floating, that is not directly attached, or it may be attached toone or both walls 76 or 75 by, for example, lamination, bonding or heatstaking. One skilled in the art will recognize that there are many typesof flow directors and concomitant manufacturing and attachment methodsthat serve to separate the walls and provide small channels for fluid topass, and several examples will be described in more detail below.

In this and other pouch embodiments disclosed herein, (referring to FIG.4A) the first wall 55 and second wall 56 may be attached at theirperipheral edges, or at other points between them, or a combination ofthe peripheral edges and discrete or continuous surfaces or linesbetween the layers. The walls may be joined by any method for joiningpolymeric sheets as known by one skilled in the art such as heat sealing(heat staking) or adhesive or solvent bonding. The conduit memberretainers may be made by joining discrete spots or lines between thefirst wall 55 and second wall 56, for example, and may also be locationswhere the first wall 55 and second wall 56 are joined together.Alternatively, in other embodiments, the conduit members may be joineddirectly to one or both walls directly as described elsewhere in thisdisclosure.

As noted above, flow directors may be located on any one or more of thesurfaces on the inside of the pouch. In some embodiments, and withreference to the pouch 52 in FIG. 5A, the inner surface 56 b of thesecond wall 56 may have flow directors as depicted by the shadedstriations extending longitudinally in FIG. 5A. This arrangement isessentially the same as that shown in FIG. 4A, except that the firstwall 55 is peeled up longitudinally to show a portion of the inside ofthe pouch 52. The flow directors may be any type of texture that tendsto keep the second wall 56 and first wall 55 separate in at least someareas of the inside internal compartment of the pouch so that liquid(urine) and air may flow without having a partial or total vacuum lockcondition—a condition wherein the walls stick together due to the airsuction and/or capillary or stiction forces between the walls. Inaddition, the flow directors may have some preferential orientation,either entirely across the surface, or on average, such that urine ischanneled from one end to the other end of the pouch as it is drawn bythe tips of the conduit members.

The orientation of the flow directors is further emphasized in FIGS.5B-5D, which show various orientations of the directors with respect tothe longitudinal (proximal to distal) axis of a pouch. FIG. 5B shows asection of a pouch wall with directors indicated by shaded striationsoriented along 0 degree vectors 82 indicating alignment with the pouchlongitudinal axis, as described below in more detail. FIG. 5C shows asection of a pouch second wall with directors indicated by shadedstriations oriented along vectors 84, indicating 15 degrees of anglewith respect to the pouch longitudinal axis. FIG. 5D shows a section ofa pouch second wall with directors indicated by shaded striationsoriented along 90 degree vectors 86 indicating orthogonality with thepouch longitudinal axis and preferred air/liquid flow direction.Depending on the structural features used to create the flow directors,they may or may not be fully aligned homogenously. That is, adistribution of channels, fibers, or whiskers may have a net orientationalong the 0 degree vector 82 orientation, but there may be adistribution of angles due to manufacturing processes such that theaverage angle of these features aligns approximately with the vector 82orientation (approximately 0 deg.).

In some embodiments, fibers 87, 88, and 89, as shown in FIGS. 5B-5D, mayserve as flow directors, and they may be attached to the wall of any ofthe layers described above and shown in FIGS. 4A-4C, or the fibers 87,88, and 89 may be attached to a substrate that is, in turn, attached toone of the pouch walls. The fibers 87 may be continuous along the lengthof the pouch or discrete, having many smaller lengths that overlap, andthe size may be lightweight, such as 1-10 denier, or heavy weight insome applications, up to 50 denier or heavier. The height of the fibers87 should be high enough to allow the fibers 87 to create a channel forfluids to flow between the fibers 87 as the pouch walls are broughttogether by force or under suction. That is, the height should be largeenough to allow urine to flow between the pouch walls without incurringa vacuum lock.

FIG. 5E shows a detailed view of a section of the second wall 56 of apouch having flow directors. In this example, the flow directors arecomprised of fibers 87 indicated by the various sized dots shown on theend of the cross-section and lines shown on the top and side surfaces.The fibers 87 are generally aligned such that fluid flows in thedirection of the arrows, which may be aligned from the proximal todistal end of the pouch. Gaps are formed between the fibers 87 whichcreate grooves for fluid flow. For example, as shown in FIG. 5F, whenthe first wall 55 and the second wall 56 are drawn together, by vacuumfor example, the fibers maintain flow channels so that fluid may flow asindicated by the arrows, the fluid being drawn, for example, by apressure differential acting on the fluid in that direction.

In some embodiments, the manufacturing process to create the substrateinvolves having fibers 87 laid down along a moving conveyor belt andthen blown with hot air to melt them together. This substrate may bedescribed as melt-blown, airlaid, or hot air through. The fibers may bemade of a single material, or multiple materials, for example, whereintwo materials (e.g., PE and PP) are joined together in small extruderssuch that each strand has both materials in a base/binder configuration,wherein the binder has a lower melting temperature. The base/binderratio may be, for example, from 1:20 up to 20:1. The final substrate(sheet) that contains the fibers may have a sheet weight of about 5-500gsm and a thickness of approximately 5-500 microns, in some exampleembodiments.

The fiber material may be a thermoplastic polymer, a thermoset polymer,or combination thereof, or a natural fiber. Examples of suitablethermoplastics include but are not limited to: polyethylene,polypropylene, polyethylene terephthalate, polyamide, polyvinylchloride, polyester, polyether, polyurethane, polytetrafluoroethylene,block-copolymer elastomers, polyamid. Examples of suitablethermosets/rubbers include but are not limited to: butyl, chloroprene,epichlorohydrin, ethylene/acrylic, ethylene-propylene, fluorocarbon,fluorosilicone, silicone rubber, natural rubber, nitrile, hydrogenatednitrile, perfluoroelastomer, polyacrylate, polysulfide, styrenebutadiene. Examples of suitable natural fibers include but are notlimited to: linen, silk, and wool.

In some embodiments, the fibers 87 are hydrophobic either because theunderlying fiber material is inherently hydrophobic, or it is treatedwith a hydrophobic compound making it non-wicking. Hydrophobicity tendsto prevent attraction (wetting or wicking) of the urine to the surface.However, depending on the nature, size, and orientation of the fibers, aneutral or hydrophilic material may be similarly functional.Additionally or alternatively, the fibers may be constructed of anonwoven material.

A nonwoven fibrous surface may be particularly slippery against skin sothat the penis does not get stuck while inserting it into the pouch,making the application of the device convenient for the operator andcomfortable for the patient. Furthermore, a nonwoven fibrous materialtends to dry to the touch rapidly when the urine is partially or fullyevacuated so that nearly all liquid can be removed quickly, reducing therisk of skin maceration.

One skilled in the art would recognize that there are many physicalshapes or materials that can maintain space between the pouch walls toprevent vacuum locking. By way of example, further embodiments are shownin FIGS. 6A-12 . For example, FIGS. 6A-6B show a perspective view and anexploded view respectively, of a pouch 92 having a plurality of elongatemembers 98, such as rods, located inside the pouch 92, between the firstwall 94 and the second wall 96. The elongate members 98 may be discreteor attached to each other, and they may be captive inside of the pouchwith or without a direct attachment. Alternatively, they may be attachedto either the first wall 94 or the second wall 96, or both by bonding ormelting with heat (e.g. heat staking). The elongate members 98 areapproximately aligned with the longitudinal axis of the pouch and theymay span the entire length of the pouch 92 or have a length shorter thanthe pouch 92.

FIGS. 7A-7B show a perspective view and an exploded view respectively,of a pouch 102 having corrugated sheet 108 located inside of the pouch102 between the first wall 104 and the second wall 106. The corrugatedsheet 108 may be captive inside of the pouch with or without a directattachment. Alternatively, the sheet 108 may be attached to either thefirst wall 104 or the second wall 106, or both by, for example, bondingor melting with heat (e.g., heat staking or thermal bonding). Thechannels 109 in the sheet 108 are aligned or approximately aligned withthe longitudinal axis of the pouch, and they may span the entire lengthof the pouch 102 or have a length shorter than the pouch 102.

FIGS. 8A-8B show a perspective view and an exploded view respectively,of another embodiment of a pouch 112 having mesh 118 located inside ofthe pouch 112, between the first wall 114 and the second wall 116. Themesh 118 may be captive inside of the pouch 112 with or without a directattachment to the first wall 114 or second wall 116. Alternatively, themesh 118 may be attached to either the first wall 114 or the second wall116, or both by, for example, bonding or melting with heat (e.g., heatstaking or thermal bonding). The grids 119 in the mesh 118 areapproximately aligned with the longitudinal axis of the pouch, and theymay span the entire length of the pouch 112 or have a length shorterthan the pouch 112.

FIGS. 9A-9B show a perspective view and an exploded view respectively,of another embodiment of a pouch 122 having ribcage 128 located insideof the pouch 122, between the first wall 124 and the second wall 126.The ribcage 128 may be captive inside of the pouch 122 with or without adirect attachment to the first wall 124 or second wall 126.Alternatively, the ribcage 128 may be attached to either the first wall124 or the second wall 126, or both by, for example, bonding or meltingwith heat (e.g., heat staking or thermal bonding). The grids 129 in theribcage 128 are approximately aligned with the longitudinal axis of thepouch, and they may span the entire length of the pouch 122 or have alength shorter than the pouch 122.

FIGS. 10A-10B show a perspective view and an exploded view respectively,of another embodiment of a pouch 132 having lattice 138 located insideof the pouch 132, between the first wall 134 and the second wall 136.The lattice 138 may be captive inside of the pouch 132 with or without adirect attachment to the first wall 134 or second wall 136.Alternatively, the lattice 138 may be attached to either the first wall134 or the second wall 136, or both by, for example, bonding or meltingwith heat (e.g., heat staking or thermal bonding). The lattice 138 mayspan the entire length of the pouch 132 or have a length shorter thanthe pouch 132.

Flow directors, including the aforementioned flow directors disclosedherein (e.g., in FIGS. 4A-10B), or other embodiments of directors notparticularly detailed here but within the scope of the disclosure, maybe made of a polymeric material that may be fabricated by injectionmolding, blow molding, layer deposition, extruding, or compressionmolding, for example. Examples of suitable thermoplastics include butare not limited to: polyethylene, polypropylene, polyethyleneterephthalate, polyamide, polyvinyl chloride, polyester, polyether,polyurethane, polytetrafluoroethylene, block-copolymer elastomers, andpolyamid. Examples of suitable thermosets/rubbers include but are notlimited to: butyl, chloroprene, epichlorohydrin, ethylene/acrylic,ethylene-propylene, fluorocarbon, fluorosilicone, silicone rubber,natural rubber, nitrile, hydrogenated nitrile, perfluoroelastomer,polyacrylate, polysulfide, styrene butadiene. Alternatively, the flowdirectors may be made of a metal such as steel, nitinol or any othersuitable metal. The flow directors disclosed herein may be hydrophobiceither due to the innate characteristics of the material or due to ahydrophobic coating applied to the material. A hydrophobic surface tendsto be non-wicking so as to prevent urine from adhering to the surface sothat it can be more readily entrained in the vacuum-driven flow of fluidthrough the pouch.

In some embodiments, flow directors may be embedded in the first wall orthe second wall, or in a middle layer. The features may be embossed oretched into the material or molded or extruded as part of thefabrication process for the sheet or film material or substrate havingthe texture. FIG. 11 illustrates an example embodiment of a pouch 142having a first wall 144 that is shown peeled up longitudinally to exposethe inner surface 146 b of the second wall 146. The inner surface 146 bhas a wave-like pattern 143 of lines that are either raised or recessedinto the inner surface 146 b. This pattern creates a flow director,which maintains flow channels between the first wall 144 and second wall146 due to the height of the lines. In some embodiments, the innersurface 144 b of the first wall 144 may have a wave-like pattern 143 inaddition to the inner surface 146 b or instead of the inner surface 146b.

One skilled in the art would recognize that there are many raisedpatterns that can be made on the inside of one or more pouch surfaces tocreate an effective flow director. Examples include straight lines,grids, and repetitive patterns such as herringbone, fish scales,diamond, picket, triangle, or arabesque. For example, FIG. 12Aillustrates an embodiment having protuberances 158 arranged on the firstwall 154 and protuberances 159 arranged on the second wall 156. Theprotuberances 158 and 159 extend into the interior cavity of the pouch152; that is, the protuberances 158 on the inner surface 154 b of thefirst wall 154 extend toward the second wall 156 and the protuberances159 on the inner surface 156 b of the second wall 156 extend toward thefirst wall 154. The protuberances 158 and 159 may contact the opposingwall to prevent the walls from coming into full contact over significantareas, thus reducing the incidence of vacuum lock. Therefore, gapsbetween the protuberances 158 and 159 create interstices (acting as flowdirectors) through which air and urine can flow. The protuberances maybe actual solid or semi-solid bumps on the inner walls that are moldedin place, or attached via melting, or bonded in place. In otherembodiments, the protuberances may be formed in the wall, like a dome,having the same wall thickness as the nominal wall.

Flow directors need not be uniformly arranged on the entire innersurfaces of the pouch. In some embodiments, flow director structures maysimply be formed or provided on inner surfaces of the pouch that arelocated in the vicinity of one or more fluid inlets within the pouch.FIGS. 12B and 12C, respectively, illustrate perspective views of pouchembodiments having flow directors provided only on specific portions ofinternal walls of said pouch.

FIG. 12B illustrates an embodiment of a pouch 155 where two teardropshaped flow director structures 157 a and 157 b are formed on one orboth of the inside surfaces of the first wall 161 a and the second wall161 b of the pouch 155 and in the vicinity of the fluid inlets of theconduit members in the pouch 155. FIG. 12C illustrates an embodiment ofa pouch 150 having a region comprising one or more flow directorstructure(s) 151, formed on one or both inside surfaces of pouch 150between the first wall 167 a and the second wall 167 b at the distal endof the pouch 150, i.e., located at a distal end of the pouch 150 in thevicinity of the fluid inlets of the conduit members inside of the pouch150.

The shape of the pouch 2 is generally rectangular with a proximal end 16that has rounded corners and a distal end 20 that is relatively blunt,as illustrated in a top view in FIG. 13 . The device 1 of FIG. 13 isfilled partially with urine 23 and it is lying on its side such that theurine 23 fills one side of the pouch 2; this circumstance may occur, forexample, if the patient lies on his side. The fluid inlet opening 12 ofthe conduit member 22 terminates near to but before the distal end 20 ofthe pouch 2 so that it cannot become blocked by the end of the pouch 2and it cannot suck the end of the pouch 2 up against the fluid inletopening 12 of the conduit member 22 which could block the influx of airand urine. In addition, the fluid inlet opening 12 of the conduit memberis proximal to the urine 25 that accumulates in the distal end 20 of thepouch 2. Thus, even in this sideways orientation, the side 21 of thepouch 2, being relatively horizontal, allows the conduit member 22 toreside relatively flat so that even when the fluid level decreases, theconduit member 22 will still be able to aspirate most of the urine 23that has accumulated to the side of the pouch 2. In embodiments, thetaper angle “a” of the pouch 2, may be as little as 0 degrees or larger,such as 15 degrees. Even with a 15 degree taper, experiments have shownthat with the device 1 on its side as shown in FIG. 13 , while exposedto suction, the device can evacuate substantially all pooled urine.Having two conduit members positioned on opposing sides of the pouch canaccommodate suction while the pouch is lying sideways in eitherdirection.

When the pouch is tilted, as in FIG. 13 , the urine level may be so lowthat the fluid inlet opening 12 is not submerged in urine. This cancause the conduit to suck in air leaving a pool of urine towards theproximal end of the pouch 2. As such, some embodiments, a conduit mayhave multiple inlets along its length. Having multiple inlets along thelength of the conduit may reduce the amount of pooled urine becausethere is a greater chance of having one of the inlets submerged in urinewhen the pouch 2 sits at various pouch orientations. In otherembodiments, a conduit may be multi-lumen with each lumen having sideopenings at various lengths along the lumen mitigate pooling at variouspouch orientations. In yet other embodiments, there may be multipleconduits of different lengths adjacent to each other such that the tipof each conduit presents a different inlet along the side of the pouch,again, to mitigate the chance of missing pooled fluid when the pouch 2resides in various tilted positions.

The pouches disclosed herein may have walls that are made of anysuitable material that is highly flexible, i.e., low in flexural modulusand/or thin-walled. In addition, the pouch material may be chosen insome embodiments so that the resulting wall has a thickness of about5-100 μm, or in some embodiments the thickness may be up to 1 mm. Thepouch is liquid impermeable and may be heat weldable, or may otherwisebe laminated, bonded, or solvent bonded, to another flexible wall.Examples of suitable materials may include but are not limited to,polyurethane, ethylene vinyl acetate, polyethylene, silicone, rubber,latex, polyolefin, or any other suitable thermoplastic. Furthermore, thepouch walls may be made fully or partially of an odor-blocking materialsuch as a polyamide, polyvinylidene dichloride, ethylene vinyl alcoholor EVOH or similar materials, or alternatively, the odor-blockingmaterial may comprise one or more films coextruded with other suitablematerials or otherwise attached to the pouch walls.

While the comfort and environment inside of the pouch is of paramountimportance, as described above, the external surface also touches thebody on and in-between the legs; although this surface is not typicallywet, it may cause a sensation or irritation to the skin over time. Assuch, the outer surface(s) of the pouch may have a layer of materialattached to aid in patient comfort. The layer may be made of suitablethermoplastics, including but not limited to: polyethylene,polypropylene, polyethylene terephthalate, polyamide, polyvinylchloride, polyester, polyether, polyurethane, polytetrafluoroethylene,block-copolymer elastomers, silicone, rubber, latex, or polyamids.Alternatively, or in combination, natural fibers may be used, includingbut not limited to cellulose-based materials such as cotton, linen,rayon, or various others such as silk or wool.

Fluid Flow System

The action of a fluid, such as air, passing through the pouch section isintegral to the function of the system with respect to the removal ofliquid and remnant moisture from the enclosed area created by the liquidimpermeable pouch. More specifically, the system may be arranged suchthat the air flow through the pouch section assists in performing twodistinct functions, both a result of the pressure differential createdbetween the pouch section and the conduit system.

The first function is to drain “pooling volumes” of urine received bythe pouch section more quickly into the conduit system; this reduces theamount of time that the weight of the urine inside the pouch can act topull the pouch downward via gravity. During use, the adhesive patch iscoupled with the body on one side and attached to the pouch section onthe other side. Any weight acting on the adhesive increases stress onthe coupling between the adhesive patch and the body, subsequentlyincreasing the risk of dislodgement of the system from its intendedlocation. Furthermore, excess fluid in the pouch can create a force onthe patient's legs due to the increased size and weight of theurine-filled device. Transfer of fluid into the conduit system and outof the device reduces these undesirable effects.

The second function is to remove any remnant moisture from the pouchsection, which may exist after drainage of larger, pooling internalcompartments of liquid. Pressure and concomitant air flow ultimatelycause the removal of remnant liquid and moisture from the pouch sectioninto the conduit system. This occurs via two independent mechanisms.

The first mechanism is physical, where negative pressure and the actionof air moving across the inside surface of the pouch wall pushes smallerurine droplets that have clung to the surface towards the conduitsystem. This mechanism is effective when air is pulled through the pouchvia the conduit system and flows over the flow directors. The unifieddesign may cause the pressure exerted by the air flow on the droplets tocreate a force that is greater than the attractive forces between theliquid and the surface, which acts to hold the droplets to the surface.As the size of the water droplet decreases, the cross-section area uponwhich the air flow has to act decreases, which in turn decreases theexertion force of the air. There will be a balance of forces thateventually results in some small droplets and remnant moisture unable tobe moved into the conduit system, which is where the second mechanism isimportant.

The second mechanism is physical, where the air moving across the insidesurface of the pouch wall causes small water droplets and remnantmoisture to evaporate and be removed from the enclosed space along withthe air itself. Evaporation is dependent on many variables; however,with respect to variables that may be controlled within the discloseddevice, volumetric air flow rate, surface area and air velocity arerelevant. All of these variables are directly proportional to the rateof evaporation. Furthermore, in embodiments having flow directors, toincrease the removal of moisture via this mechanism, the size andorientation of the flow directors with respect to the conduit system maybe balanced to adequately expose the urine droplets to the air velocityacross different areas within the enclosed space. In experiments, someof the pouch embodiments disclosed herein can be evacuated of urine anddry to the touch within 0.5-15 minutes depending on factors such as theamount of wetness inside the pouch, rate of air flow velocity, vacuumpressure, ambient temperature & humidity, hydrophobicity of thematerials, and type and size of flow directors.

The air and urine flow pathways are illustrated schematically in FIGS.14-16 in the context of the urine removal device 1 described previouslyherein. FIG. 14 shows an empty pouch, without urine, with air flow pathsdepicted by arrows. In embodiments disclosed herein, the air flow isdriven by a pressure differential that may be provided by a pressure orvacuum source, which draws air out, as indicated by arrow 170, throughthe suction source tube 24. The arrows 160 depict air flowing into thepouch 2 through the air ports 30. The air is entrained in the pouch 2 asindicated by arrows 162, after which it flows from the proximal end 16toward the distal end 20 of the pouch 2 as indicated by arrows 164. Nearthe distal end of the pouch 2, the air is pulled in through the firstconduit member 18 and the second conduit member 22 through fluid inlets15 and 12 respectively, as indicated by arrows 166, where it travelsthrough the conduit members as indicated by arrows 168. Finally, the airis drawn out through the suction source tube 24 by the applied pressuredifferential. Notably, in embodiments such as this, the air ports 30 arelocated near the proximal end 16 of the device 1. This allows the airflow as indicated by arrows 164 to pass by the penis (not shown) becausethe aperture 3 through which the penis is inserted is distal to the airports 30.

Now with reference to FIG. 15 , which shows a device 1 in an arrangementthat is otherwise the same as that in FIG. 14 , except that liquid(urine 174) is present in the pouch 2 as indicated by the shading andthe droplets. The arrows 160 depict air flowing in through the air ports30. Next, the air is entrained into the pouch 2 as indicated by arrows162, after which it flows from the proximal end 16 toward the distal end20 of the pouch 2 as indicated by arrows 164. In doing so, the airentrains the urine 174 such that it flows along with the air flow asindicated by arrows 165. Near the distal end, the air and urine arepulled in through the first conduit member 18 and the second conduitmember 22, as indicated by arrows 166 where the mixture travels throughthe conduit members 18 and 22 through fluid inlet 15 and 12respectively, as indicated by arrows 169. Finally, the air/urine mixtureis drawn out through the suction source tube 24 by the applied pressuredifferential as indicated by arrow 172. Thus, the air and urine flowfrom the proximal to the distal end of the device 1 is driven by theconduit members 18 and 22 having their inlet at the distal end of thepouch 2. This flow conduit arrangement tends to pull the urine away fromthe penis, which resides in the pouch 2 toward the proximal end 16 ofthe device 1, resulting in a more comfortable experience for the patientbecause the urine does not pool or otherwise reside around the penis foran excessive amount of time. Additionally, as a result of the airflowwithin pouch 2, the air/microclimate within the pouch 2 is quicklydehumidified, and as a consequence the discomfort felt by the patient isminimized.

Now with reference to FIG. 16 , which shows a device 1 in an arrangementthat is otherwise the same as that in FIG. 14 , except that dampness ispresent in the pouch 2, as indicated by the shading. The dampness is aresult of residual urine in the pouch 2 and/or sweat from the patient.As noted above, arrows 160 depict air flowing in through the air ports30. Next, the air is entrained into the pouch 2 as indicated by arrows162, after which it flows from the proximal end 16 toward the distal end20 of the pouch 2 as indicated by arrows 164. In doing so, the air flowsacross the damp surfaces and through the damp air resulting inevaporation as depicted by arrows 173. The evaporation is enhanced bythe forced convection of the air flowing through the pouch 2. Near thedistal end 20, the air and urine vapor are pulled in through the firstconduit member 18 and the second conduit member 22 through the fluidinlets 15 and 12 respectively, as indicated by arrows 166 where themixture travels through the conduit members 18 and 22 as indicated byarrows 171. Finally, the air/urine vapor mixture is drawn out throughthe suction source tube 24 by the applied pressure differential asindicated by arrow 173. Thus, the air and urine vapor flow from theproximal end 16 to the distal end 20 of the device 1 is driven by theconduit members 18 and 22 through their inlet at the distal end of thepouch 2.

In the illustrations shown in FIGS. 14-16 , the penis would generally beinside of the pouch, although for clarity, it is not shown. In general,the flow of air through the pouch provides rapid drying of the interiorenvironment of the pouch, which includes the penis, which may alsoproduce sweat in the form of vapor or condensed vapor. The flowdirectors disclosed herein may increase drying speed as described above.Furthermore, if the flow directors and other materials inside of thepouch are made of nonabsorbent materials, drying may be furtheraccelerated, resulting in a lightweight system with little or noaccumulated urine inside. For example, if the nonwoven fiber surface ismade of a material that is nonabsorbent, liquids will tend not to absorbor adhere to the pouch materials making the liquids easily entrainedwith the air flow, leading to faster drying.

In some embodiments, air may also flow into the pouch through the gapsaround the location where the adhesive patch 8 attaches to the body.These gaps, do not adversely affect performance because they are nearthe proximal end 16 of the device 1 and, since the net flow rate in thepouch 2 is away from the proximal end, the flow may ensue in much thesame manner as if air is drawn in through the air ports 30. However, ifthe gaps are very large, they may permit leakage of urine in theproximal direction onto the patient. Furthermore, in some embodiments,air ports may not be necessary because the air gaps around the adhesivepatch 8 may provide adequate ventilation to support the suction pressurewithout collapsing the pouch 2 in a vacuum lock condition.

One skilled in the art will recognize that there are other ways forproviding air to the pouch, such as through ports and valves or throughgaps, voids, or apertures where the device 1 mounts to the body; all ofsuch variations are within the scope of this disclosure. Next, turningto FIGS. 17A-17H, the proximal end 16 of the urine removal device 1 isonce again shown illustrating the air ports 30 through a wall of pouch2, for example the first wall 4 of the pouch 2. The air ports 30 maycomprise one or more small holes or slits, and the risk of leakagethrough the air ports 30 is reduced by the direction of flow away fromthe air ports 30 and because the cavity inside of the pouch 2 driesquickly. However, in some circumstances leakage may be caused by, forexample, a rapidly urinating patient filling the pouch, the patient ornurse squeezing the pouch, the patient rolling onto it, suction failure,tube kinking, vacuum suction failure, or general handling by acaretaker, or some combination of these factors. In some embodiments, avalve may be used in place of or in addition to the aforementioned airport 30 to create some resistance to the leakage of urine out of thedevice. One skilled in the art would recognize that there are many valvetypes and styles that can provide this function, for example a slitvalve 45 a, an umbrella or flapper valve 45 b, a cross-slit valve 45 c,a duckbill valve 45 d, a flutter valve 45 e, a check valve 45 f, and adome valve 45 g are shown in FIGS. 17A-17H as examples. These valves maybe located at the location where the air ports 30 are located orelsewhere on the pouch 2 generally toward the proximal end of the pouch2 or toward the middle of the pouch 2 in some embodiments.

Another embodiment of a pouch 176 is illustrated in FIG. 18 in anexploded view showing three layers: a first wall 178, a second wall 180,and a valve layer 182. Air ports 184 and the pouch aperture 181 are alsoshown in FIG. 18 , but for clarity, other features are not shown. Thevalve layer 182 provides a one-way valve to prevent urine from flowingproximally toward the air ports 184. The valve layer 182 may be attached(or sealed) to the first wall 178 of the pouch 176 at or near theproximal end 185 of the valve layer 182 or at the sides 186 of the valvelayer 182 or at the proximal end 185 and the sides 186. The distal end187 of the valve layer 182 is at least partially open, that is, notattached or sealed to the first wall 178, so that air may flow betweenthe valve layer 182 and the first wall 178 in the direction of the arrow188. This will allow the air to interact with any urine or liquid vaporin the device in the same manner as shown in FIGS. 14-16 as describedabove. However, if the bag is tilted or squeezed, liquid may move towardthe proximal end 183 of the pouch 176 and reach the distal edge 187 ofthe valve layer 182 wherein the liquid will generally force the distaledge 187 against the first wall 178, thus preventing backflow into theair ports 184. This operation is similar to a flutter valve.

Structural Support System

As described in more detail above, the conduit system has at least oneopening in the proximal and the distal end, with fluid communicationbetween the ends. The open end or ends are intended to divert fluidreceived by the pouch section away from the penis through the conduitsystem to an opposing end. The conduit system may include one or moreindependent lumens, or be configured to create a lumen when coupled withthe pouch section. The system may be composed of a single component andsingle material, or be derived from a combination of various componentsand materials. The construction is chosen, so that a balance is struckbetween flexibility and rigidity such that the pouch may bend or flexwithout obstructing the fluid communication between the proximal anddistal ends of the pouch.

The conduit system is arranged within the pouch such that fluidcommunication between the enclosed area of the pouch and the lumen ofthe conduit system remains open and substantially unobstructed. Morespecifically, the coupling is devised so that the movement of either thepouch or the conduit system, such as during bending or twisting of bothsections together or of the individual sections in relation to eachother, will not reduce the ability for fluid through the pouch and intothe conduit members. That is, the intersection between the conduitsystem and the pouch should not restrict the flow to a point where it isthe rate-limiting factor of the system. This may be achieved in variousembodiments that tend to keep the pouch and conduit system in arelatively fixed orientation such that they do not appreciably deformrelative to each other. In these embodiments, the pouch resists kinkingand bending and stays relatively congruent with the conduit system sothat flow of air and urine is maintained. This may be achieved, forexample, by altering part of either section so the stiffness becomesmore similar to that of the other section, or by coupling the sectionsso that the more flexible portion (pouch) is held in place by thestiffer portion (diverter system). For example, FIG. 19 shows such ascenario wherein the pouch deforms, but the conduit members stay intheir place relative to the pouch to provide a restoring force due totheir stiffness.

In an embodiment, the conduit system may be comprised of one or moresingle or multi-lumen lumen extrusions and the pouch may be anessentially elongated shape with a proximal end near the body and adistal end away from the body. The conduit system may run along thepouch section to have an open end near the distal end of the pouchsection and an outlet near the proximal end of the pouch. The conduitsystem may be coupled to the pouch section along at least part of theoverlapping length such that movement of the conduit system causes thecoupled areas to move in tandem. In some embodiments, the addedstructural stiffness is due to the size of the conduit members ascompared to the thickness of the pouch. For example, a pouch may beflexible because it is made of a polymer having a wall thickness of 50microns, or even 500 microns, for example, while the conduit members maybe made of a polymer and have a diameter of 1 mm-10 mm; when coupledtogether, the resulting device has a bending stiffness that is orders ofmagnitude higher than the pouch alone, which may have negligible bendingstiffness.

As shown in FIG. 19 , the urine removal device 1 is shown with adeformed configuration overlay using dotted lines to illustratedeformation. When the device 1 is loaded such that the pouch 2 deforms,the pouch 2 may rise at the distal end 20 or twist, as shown as thedeformed pouch 2′. Likewise, the second conduit member 22′ deforms withthe pouch 2 to a deformed pouch 2′ while staying in place in thedeformed pouch 2′ because the second conduit member 22′ is retained bythe conduit member retainer 26′ which keeps the second conduit member22′ toward the outer edge of the deformed pouch 2′. Thus, the distal end20 of the deformed pouch 2′ stays relatively straight and taught anddoes not fold or collapse and the conduit members 18 and 22′ are notblocked so that they can still evacuate air and urine. Furthermore, thefirst wall 4 and second wall 6 can remain relatively adjacent to eachother even while the device 1 is loaded and deformed to preventsignificant contact, creases, or folding which may stifle the flow offluids.

One skilled in the art will recognize that there are other arrangementsof a conduit system and pouch that provide the structural integrity tokeep the fluid flow system operable. Some example embodiments are shownin FIGS. 20-35 , but other designs, permutations, and configurations arewithin the scope of this disclosure. For clarity, the embodimentsdisclosed herein, in particular the embodiments illustrated in FIGS.20-35 , may not show all of the features, such as air ports, as shown inother embodiments (e.g., FIG. 1 ) even though they may have thesefeatures; emphasis instead being on the differences between the variousembodiments.

FIGS. 20-22B illustrate embodiments having different conduit systemarrangements. Now with reference to FIG. 20 , which shows a device 201having an alternative conduit member arrangement wherein the firstconduit member 210 and the second conduit member 211 attach to a suctionsource tube 214 at the proximal end 213 of the urine removal device 201.In this embodiment, the first conduit member 210 and the second conduitmember 211 reside outside of the pouch 202 except near the distal end212 of the pouch 202 where the first conduit member 210 enters the pouch202 at a first pouch entry point 219 and the second conduit member 211enters the pouch 202 at a second pouch entry point 220 so that thedistal tips of the first conduit member 210 and second conduit member211 reside inside the pouch 202 to function similarly to that describedabove, in urine removal device 1. The pouch 202 may be attached to thefirst conduit member 210 and the second conduit member 211 continuouslyalong the outer periphery of the pouch 202 or at discrete locations sothat the rather flaccid pouch can be supported by the conduit members210 and 211 to prevent excessive bending and kinking.

In another embodiment of urine removal device 1, illustrated in FIG. 21, conduit members 250 and 251 are disposed external surfaces to thepouch 203, wherein each conduit member 250 and 251 is in fluidcommunication with the internal compartment, defined by pouch 203,through one or more connecting channels 205. The distal ends 206 and 207of the conduit members 250 and 251, respectively, may be external to thepouch 203 and blocked (i.e., no flow in or out).

FIG. 22A illustrates another embodiment of a urine removal device 221having an alternative conduit member arrangement with a first conduitmember 230 and a second conduit member 231 located along the middle ofthe pouch 223 connecting to the suction source tube 234 at the proximalend 233 of the urine removal device 221. The pouch 223 may be attachedto the first conduit member 230 and the second conduit member 211continuously along the outer periphery of the pouch 222 or at discretelocations so that the rather flaccid pouch can be supported by theconduit members 230 and 231 to prevent excessive bending and kinking.Furthermore, in other similar embodiments, such as the urine removaldevice 241 shown in FIG. 22B, the conduit system may comprise a singleconduit member 253 located along a midline of the pouch 252. In each ofthe aforementioned embodiments, devices 221 and 241, the conduit membersmay run entirely inside of the pouch or may be located partially outsideof the pouch except where the distal tips reside at the distal endinside of the pouch.

In some embodiments, the pouch may have a domed profile such that thefirst wall of the pouch is spaced away from the inner layer, either dueto the penis propping the pouch up or by the structure of the pouchcreating an open cavity inside of the pouch as shown in FIGS. 23A-23C.As illustrated in FIG. 23A, the urine removal device 261 has a firstconduit member 260 and a second conduit member 263, both of which areattached to the first wall 262 of the pouch 264 with conduit memberattachments 266 which may, for example, be adhesive bonds or thermalwelds (i.e., heat stakes). In this embodiment, the conduit members 260and 263 are curved out of plane so that the first wall 262, which isattached, is tented away from the second wall 265 by a height “h” asshown in FIG. 23B. This allows the first wall 262 to reside above thepenis 34 as shown, or depending on the height “h,” the first wall 262 itmay still contact the penis 34 but may do so with relatively low contactforce due to the domed shape. FIG. 23C is a cross-sectional view throughplane B-B in FIG. 23A. FIG. 23C illustrates how the first conduit member260 may be attached to the first wall 262 via a conduit memberattachment 266 and similarly the second conduit member 263 may beattached to the first wall 262 via a conduit member attachment 266; theconduit member attachments 266 may be located on the top, the side, oranywhere around the circumference of the conduit member. Embodiments,such as that shown in FIGS. 23A-23C, where the first wall 262 isattached directly to the conduit members 260 and 263, may provide moreinterior pouch internal space as compared to embodiments wherein theconduit members are enveloped by the walls (e.g., see FIG. 1D) becausein the former, the pouch walls 262 and 265 are not tacked togetherinboard of the pouches, leaving a more open interior space.

There are many other embodiments of urine removal devices having variousarchitectures that are within the scope of this disclosure and variouscombinations of those included herein are contemplated. By way ofnonlimiting example, some of these are shown in the figures. Forexample, one embodiment is shown in a view from the inner side, that is,the patient-facing side, in FIG. 24 . The urine removal device 271 has arelatively simple design having relatively fewer parts, including apouch 272 and a round adhesive patch 274 surrounding an aperture 275.

Another embodiment is shown in FIG. 25 , the urine removal device 276having an adhesive patch 279 attached to a pouch 278 which includes asuction source tube 277 at the distal portion of the pouch 278 that canbe connected to a vacuum source to provide suction to the interior ofthe pouch 278. A similar urine removal device 281, as shown in FIG. 26 ,has a pouch 282 that is tapered toward the distal end 287 where asuction source tube 286 is attached. The device 281 may have an adhesivepatch 284 that is round, encircling an aperture 285 where the penisenters the pouch 282 in a similar fashion to other embodiments disclosedherein. In yet another embodiment, FIG. 27 shows a urine removal device291 with a similar layout to the device of FIG. 26 with an adhesivepatch 294 that is round, encircling an aperture 295 where the penisenters the pouch 292; this embodiment includes a gusset 298 arrangedalong the longitudinal axis or at some angle from the proximal to thedistal end of the pouch 292. The gusset 298 includes at least one pleat,which is folded as the pouch 292 lays flat, but may open/unfold toincrease surface area and internal compartment as the pouch 292 expandsdue to air or fluid that may accumulate inside of the pouch 292. Asuction source tube 296 is located at the distal end and in fluidcommunication with the pouch 292. Another embodiment is shown in FIG. 28; the urine removal device 301 having an adhesive patch 304 that isround, encircling an aperture 305 where the penis enters the pouch 302,a suction source tube 306 at the proximal end connecting to a firstconduit member 308 and a second conduit member 310 both of which extendto the distal end 309 of the pouch 302 where they curve toward thecenter of the pouch 302 to conform to the tapered shape of the pouch302.

Now with reference to FIG. 29 another embodiment of a urine removaldevice 311 is illustrated having a suction source tube 316 at itsproximal end 313 that fork or wishbone external to a pouch 312 into afirst conduit member 318 and a second conduit member 320, both of whichextend to the distal end 319 of the pouch 312 which has a blunt, flatend. In this another embodiments, the conduit system provides arelatively stiff frame that provides structure to the device 311 toprevent excessive bending, twisting, buckling, and creasing, which mayslow the flow of urine. FIG. 30 shows another embodiment of a urineremoval device 321 having a suction source tube 326 at the proximal end323 that attaches to a conduit member 328 that extends along the axis ofthe pouch 322 to the distal end 329 of the pouch 322. The device 321 hasan adhesive patch 324 that is circular, the adhesive patch 324 having anaperture 325 providing access to the pouch 322. Another embodiment of aurine removal device 331 having wings is shown in FIG. 31 . The device331 includes a pouch 332 having a first wing section 337 a and a secondwing section 337 b on the opposite side. Similar to other embodiments,the device 331 may include a suction source tube 336 attached to a firstconduit member 338 and a second conduit member 340 both of whichterminate near the distal end 333 of the pouch 332. The conduit members338 and 340 may extend along the periphery of the pouch 332 conformingto the wing shape as shown to provide structural support to retain theshape of the pouch. An adhesive patch 334 may be disposed on the pouch332, and an aperture 335 protrudes through the adhesive patch 334 andthe pouch 332 to provide access to the inside of the pouch 332. In somecircumstances, the device 331 may reside sideways either because thepatient is on his side, or because the device 331 is laying sideways,for example between the patient's legs. In such cases, urine within thepouch 332 may pool in one of the wings (337 a and 337 b) due to gravity,and once in the wing, the urine can be captured so that it does nottraverse proximally or medially such that it contacts the penis. In thissense, the wings 337 a and 337 b tend to shield the penis from the urinewhen the device 331 is oriented sideways.

Now with reference to FIG. 32 which shows a urine removal device 341having a suction source tube 346 at its proximal end 349; the suctionsource tube 346 bifurcates into two channels forming a pouch conduitmember 347 a and an attachment conduit member 347 b. The pouch conduitmember 347 a is a conduit to provide vacuum to the pouch 348 similar toother embodiments disclosed herein (e.g., FIG. 1 ) in that it connectsto a first conduit member 349 a and an opposing second conduit member349 b to draw out air, urine, and vapor as disclosed herein. The conduitmember 347 b is connected to a body attachment 344 which, like theadhesive patches disclosed herein, may have an adhesive for adhering tothe body. However, in this embodiment, the body attachment 344 may haveair flow channels in fluid communication with the skin to draw the bodyattachment 344 to the body so that the device 341 stays adhered to thebody around the penis 34. reducing the risk of urine leakage

In this and other embodiments disclosed herein, the suction pressure canbe regulated or calibrated to provide enough vacuum to remove moisturefrom the pouch without having excessive suction that may causediscomfort, sensation, or necrosis on the penis or surrounding skin.Such regulation may be accomplished by adjusting the care facility'svacuum source, adjusting the vacuum pump operatively attached to theurine removal device, or providing a valve or other flow restrictor onthe suction source tube or any tubes or apparatus' in fluidcommunication with the suction source tube. In embodiments, the suctionsource tube may not be a tube, but may be a fitting or connectordirectly attached to the pouch and providing fluid communication betweenan inner cavity of the pouch (or conduit members or channels) and theoutside of the pouch.

In various embodiments, the conduit members may be made of any suitablepolymeric material. Nonlimiting examples of thermoplastics includepolyethylene, HDPE, polypropylene, polyethylene terephthalate,polyamide, polyvinyl chloride, polyester, polyether, polyurethane, andblock-copolymer elastomers. Nonlimiting examples of thermosetpolymers/rubbers include butyl, chloroprene, epichlorohydrin,ethylene/acrylic, ethylene-propylene, fluorocarbon, fluorosilicone,silicone rubber, natural rubber, nitrile, hydrogenated nitrile,perfluoroelastomer, polyacrylate, polysulfide, polytetrafluoroethylene,and styrene butadiene. The conduit members may be sized such that theydo not take up excessive space in or around the pouch but they are largeenough to provide adequate support to prevent the pouch from kinking orbending excessively as described elsewhere in this disclosure. As such,the inner diameter of the tubes may be from approximately 1 mm-9 mm andthe outer diameter may be from 2 mm-10 mm while the wall thickness maybe in a range from 0.5 mm-5 mm or the wall thickness may be about 15-25%of the outer diameter in some embodiments. More particularly, in someembodiments, the conduit members may have an inside diameter of about2.8 mm and an outside diameter of about 3.9 mm, while the suction sourcetube may have an inside diameter of 6.5 mm and an outside diameter ofabout 8.5 mm. The durometer of the conduit members may be approximately35-85 Shore A in some embodiments.

FIGS. 33A-33B illustrate embodiments having a sleeve that covers thepenis inside of the pouch, such that the sleeve serves like a fluttervalve to prevent backflow of urine. The urine removal device 351 has asleeve 357 with a proximal end 361 that is closed and has an aperturethat is attached to the aperture 355 of the pouch 352 (to the innerwall, not shown, of the lower layer of the device 351) where it may bejoined by any suitable method of joining polymers such as gluing,bonding or thermal bonding (e.g., heat staking). The sides of the sleeve357 may also be partially attached to the pouch in some embodiments. Thesleeve 357 covers the aperture 355 to the pouch 352 and extends over thepenis (not shown), which protrudes through the aperture 355. The distalend 362 of the sleeve 357 is open such that it may reside against thetwo walls of the pouch 352 but when fluid bears upon it from theproximal end, that is from the penis, the sleeve 357 can gap open andallow urine through to the distal end 359 of the pouch 352. However, ifurine bears upon it from the distal end 359, the sleeve 357 will tend toclose around the penis as the force of the urine causes the sleeve 357to bear down itself. This action is similar to that of a flutter valve.In FIG. 33A, the second wall is not shown because it is below the firstwall 363 of the pouch 352, as the pouch 352 is otherwise similar toother embodiments discussed herein and, for example, shown in FIG. 1 .The embodiment shown in FIG. 33B is similar to that shown in FIG. 33A,having a sleeve 377 attached to the pouch 372. However, the sleeve 377has a gusset 380 that may be a pleat or a fanfold. The gusset 380 tendsto unfold laterally when the sleeve 377 is pressed outward, such asforced by the penis as it passes through the aperture 375, or by flowingurine; the unfolding increases the surface area of the sleeve 377 andhence increases coverage over the penis to shield it from the backflowof urine.

Another embodiment having a gusset in the outer wall of the pouch isshown in FIG. 34 . The urine removal device 381 shown may have a gusset387 extending down a midline from the proximal end 383 of the pouch 382toward the distal end 389 of the pouch 382. The gusset 387 may beconstructed as a single or multiple pleat, or fanfold, that serves toincrease the surface area of the pouch 382 as the pouch 382 expands dueto, for example, insertion of the penis, air, gas, or urine pressurefrom within the pouch 382. Notably, the gusset 387 may make it easierfor the operator to install the device 381 on the patient because thepleats enhance the ability of the operator to manipulate the device 381around the penis while attaching it.

An embodiment having a domed pouch shape is illustrated in FIG. 35 . Theurine removal device 391 has a pouch 392 which has a first wall that isdivided into multiple sections, for example, four sections in thisembodiment, a first section 393, a second section 394, a third section395, and a fourth section 396 that are joined together through alongitudinal seam 398 running proximal to distal along the pouch 392,and a lateral seam 397 running transversely across the pouch 392. Thesections may be fabricated by cutting them in specific two-dimensionalshapes having curved or straight edges, such that when they are joinedvia the seams, they form a domed shape as illustrated in the pouch 392.The domed shape provides space inside of the pouch 392 to reduce oreliminate contact of the pouch 392 with the penis. One skilled in theart will recognize that, depending on how the sections are shaped, thepouch 392 may have a tent-like shape with substantially flat sectionsrather than a dome shape that is typically substantially curved.

In some circumstances, it may be desirable to easily acquire a sample ofurine for analysis, for example, for testing pH, or testing for nitratesor bacteria. A urine removal device 401 having a urine sample port 407is shown in FIG. 36 . The urine sample port 407 is located on the pouch402 and it may capture urine from the pooled urine in the pouch 402. Insome embodiments, the urine sample port 407 may be a module that can beremoved from the pouch 402 after it is at least partially filled withurine, and periodic sampling may be conducted by inserting an emptymodule to replace the used module; after a period of time, the newmodule will be exposed to urine and it may be removed for sampling. Inother embodiments, the urine sample port 407 may be a self-sealingmembrane that can be punctured with a needle to aspirate a small amountof urine. In other embodiments, a sensor may also reside in the port tomeasure a physical or biological metric such as temperature, sediment,weight, color, blood, bacteria, or specific gravity for example. Thesensor may be in contact with the fluid or the air/vapor space inside ofthe pouch depending on the type of sensor and metric being measured. Thesensor may measure pressure, moisture, humidity, weight in the pouch, orany other relevant metric relevant for urinary incontinence patients.The sensor output may be used to automatically control the vacuum sourceby changing the applied pressure or turning it on or off, for example.While the urine sample port 407 is shown located toward the distal end409 of the device 401, in other embodiments, it may be located in anyother location such as on the proximal or middle region of the pouch402.

Body Attachment

In the embodiments disclosed, the urine removal device may be attachedat the base of the penile shaft, scrotum, and abdomen. There are severaladvantages and challenges of having an interface that is affixed on thegroin, pelvic and abdominal region. In addition to the shape of theadhesive, the shape of the orifice, method of application (differentpeel points), and material of the adhesive may be tailored to this areaof anatomy.

Due to a combination of factors, external collection systems facechallenges with patient attachment as well as dislodgement. Variation inpatient anatomy creates challenges in a one-size-fits-all solution.Genital skin is sensitive and prone to pain, which limits the strengthof adhesive able to be used. The abdominal and genital region may alsohave various creases and folds that are unique to each patient. Movementof legs and hips causes significant bending, elongation, and compressionof genital and perineal skin, requiring unique functions of both theadhesive and connected materials. Lastly, temporary containment of urineinside of an enclosed space increases weight, and subsequent force,acting on the adhesive, exacerbating the risk of dislodgement.

An embodiment of an adhesive patch 410 is illustrated in FIG. 37A. Theadhesive patch 410 has an aperture 415 suitable to fit over the shaft ofa penis and a wide proximal end 412 and a wide distal end 414, whichattach to the lower abdomen and scrotum respectively, as shown in FIG.2C. In embodiments, the adhesive patch 410 may have a narrowed centralsection 424 defined by concave sidewalls 420 as shown in FIG. 37A. Thewide proximal end 412 provides a large surface area to improve adhesionto the body while stabilizing against twisting motions where it attachesto the suprapubic region. The width of the proximal end 412 may beapproximately 15 cm across or between 2 and 30 cm across in embodiments.The proximal end 412 may have one or more slits 416 dividing theadhesive patch 410 into proximal tabs 417. Likewise, the distal end mayhave at least one slit 418 dividing the adhesive patch 410 into distaltabs 419. The slits 416 and 418 can reduce tension or compression of theadhesive patch 410 during body movement by providing a relief betweeneach section of attached skin that is deforming, thus allowing theadhesive patch 410 to deform with the body without excessively resistingthe motion which can cause discomfort or lead to dislodgement. The slits416 and 418 may be straight cuts or, as shown, they may be approximately“v” shaped or any other shape, and in some embodiments having roundedcorners to be more gentle and atraumatic to the skin.

The distal end 414 may be narrower than the proximal end 412 so that itfits onto the scrotum. The width of the distal end 414 may beapproximately 14 cm across or, for example, from 2 cm to 30 cm in someembodiments.

The proximal end 412 and the distal end 414 attach to the suprapubicregion and scrotum respectively, while the central section 424 laysaround the penile shaft. As such, the central section 424 is narrowerthan the proximal end 412 and distal end 414 of the adhesive patch 410.The central section 424 may be approximately 9 cm across or from 5 cm toabout 20 cm in some embodiments. The topology consists of rathervariable surfaces in the anatomy in the region of the central section424 so the reduced width can lessen the contact, and therefore theforces transferred, due to movement of, for example, the legs orscrotum, which can reduce the incidence of dislodgment of the adhesivepatch 410. Furthermore, when the adhesive patch is applied around thepenile shaft, the operator may press the large surface areas of theadhesive patch 410 onto the large surface areas of the body, for exampleby pressing the wide proximal end 412 onto the suprapubic region and thesomewhat less wide distal end 414 onto the scrotum, while the centralsection 424 seats down around the shaft of the penis. The narrow,concave shape of the central section 424 facilitates this sectionseating deep enough to seat against the skin adjacent to the shaft ofthe penis without hanging up or being held back by the adjacent skinwhich has a relatively topology in the pubic region.

FIG. 37B shows the adhesive patch 410 with the layers separated on acorner to more clearly show the different layers in this embodiment. Thesubstrate layer 421 is a fixed layer in that it is permanently attachedto the pouch (not shown, but see FIG. 1B) on its outer surface 421 a andit is attached to the adhesive layer 422 on its inner surface 421 b. Theadhesive layer 422 may comprise a single adhesive layer or a layup of aplurality of layers configured to conform with skin on one side and thesubstrate layer 421 on the other side. The substrate layer 421 may becoupled to the pouch by thermal welding (heat staking), bonding withsolvents or adhesives, or any other method for attaching thin layers.The substrate layer 421 is generally provided coupled to the pouch sothat the adhesive patch 410 is already in place, but, in someembodiments, it may be provided uncoupled so that the operator attachesit to the pouch before use. The substrate layer 421 may be made of anymaterial that allows it to adhere to both the adhesive layer 422 and thepouch; examples include but are not limited to a single or a mixture ofa natural or thermoplastic or thermoset polymer in sheet, film, woven ornon-woven fabric form; example materials include polyethylene,polypropylene, thermoplastic elastomer (TPE), polyurethane, EVA(ethylene-vinyl acetate), nylon, rayon, etc. In some embodiments, thesubstrate layer 421 may have a peel strength (relative to the adhesivelayer 422) greater than 0.1N/cm.

The adhesive layer 422 is sandwiched between the substrate layer 421 andthe release liner 423. The inner surface 422 b (not shown) of theadhesive layer 422 is suitable for attachment to the body in the areassurrounding the penis including the scrotum, groin, and suprapubic area.The adhesive layer 422 is amenable to adhesion and removal from skineven with hairs emanating from the skin, while being flexible enough tomove with the skin without peeling off. The peel strength with respectto steel can be approximately 0.1-5 N/cm in some embodiments. Oneskilled in the art will recognize that there many candidate materialsthat will adhere to the skin for the duration of urine capturing, adhereto the substrate layer 421, be easily removable without excessivelypulling on the skin and hair, and leave behind little or no residue onthe skin. For example, porous or nonporous silicone adhesives may beparticularly suitable as they are comfortable to the patient and mayleave no perceptible residue. Other candidate materials includepressure-sensitive adhesives, namely a variety of rubber-basedmaterials, gel-matrix type adhesives like hydrocolloids and hydrogels,and thermoplastic-based adhesives including polyurethanes and acrylicsas well as natural adhesive obtained from various plants or animals.

The release liner 423 covers and protects the adhesive layer 422 beforeuse, that is, during manufacturing, shipping, and handling. The releaseliner 423 should be easy to release from the adhesive layer 422 so thatthe adhesive does not stretch and rebound when the operator peels thelayers apart, as this may cause the adhesive patch 422 to fold and stickto itself. The release liner 423 should have a peel strength away fromthe adhesive that is less than both the peel strength between theadhesive layer 422 and the substrate layer 421, and less than the peelstrength between the substrate layer 421 and the pouch. One skilled inthe art will recognize that there are many candidate materials that aresuitable to protect the adhesive layer 422 in such a way, such as, forexample, paper-based liners including different combinations of coatedand densified kraft papers and laminated papers, or film-based linerssuch as high-density polyethylene and polyester thermoplastics.Additionally, the use of release agents along with the release linersmay be used.

One or more of the layers in the adhesive patch may be perforated toallow sweat to evaporate, which tends to reduce skin maceration. Withreference to FIG. 38 , an adhesive patch 430 is shown having a substratelayer 441 with perforations 444 shown in the outer surface 441 a; inthis and the following figures, while the reference numeral points toone perforation, it pertains to the entire array of perforations shown.The perforations 444 may channel through the entire thickness of thesubstrate layer 441. Alternatively, only the adhesive layer 462 may beperforated 465, as shown in FIG. 39 , for improving sweat evaporation.In this adhesive patch 450, the substrate layer 461 is not perforatedand the release liner 463 need not be perforated. Finally, as shown inFIG. 40 , the adhesive patch 470 both the substrate layer 481 and theadhesive layer 482 have perforations 485 to further enhance sweatevaporation from the skin.

One skilled in the art will recognize that there are many differentshapes of the adhesive patch that can be effective to fit within theanatomy around the penis and attach to the suprapubic area and thescrotum while not excessively interacting with the legs and groin area,in what is a geometrically complex area of the male anatomy. FIGS. 41A-Lillustrate several embodiments having various shapes as nonlimitingexamples; in the examples, the aperture identified designates the regionthrough which the penis is placed for entry into the pouch and proximalis upward on each figure. FIG. 41A shows an adhesive patch 490 that iscircular and centered around an aperture 491. FIG. 41B shows an adhesivepatch 492 having a proximal section 494 that is high and broad and adistal section that is round, while the adhesive patch 495 of FIG. 41Csimilarly has a proximal section 496 that is high and broad but hasscalloped sides 497. The adhesive patch 498 shown in FIG. 41D has ashape that is narrow around the aperture 500 with a high proximalsection 499 opposed by a round distal end. The adhesive patch 501 shownin FIG. 41E has a high and broad proximal section with proximal flanges502 and a round distal end. The adhesive patch 503 shown in FIG. 41F hasa wide shape that is short proximally and has scallops 504 on the sides.The adhesive patch 505 has a second aperture 506 above the primaryaperture 507, the second aperture being oval and extending laterallywider than the primary aperture 507, as shown in FIG. 41G. The adhesivepatch 508 shown in FIG. 41H has a middle set of flanges 509 on each sideand a lower set of flanges 510 near the distal end of the patch 508.FIG. 41I illustrates yet another embodiment wherein the adhesive patch512 has a large, bulbous proximal section 511 and a pair of lateral tabs513 next to the aperture 514. Similarly, the adhesive patch 515 shown inFIG. 41J has a bulbous proximal section 516 and large tabs 517 extendinglaterally. The adhesive patch 518 shown in FIG. 41K has a butterflyshape having large proximal wings 519, smaller pointed distal wings 520,and a keyhole-shaped aperture 521. Finally, FIG. 41L shows an adhesivepatch 522 which has a proximal slit 523 along a top edge and a distalslit 526 along a bottom edge, an aperture 525 having an oval shape, anda narrow central section 524 on both sides of the aperture 525.

Now with reference to FIGS. 42-44C which show the adhesive patch ofFIGS. 37A-B described above, along with two variations thereof. Theadhesive patch 530 of FIG. 42 has an oval aperture 535, a proximal endhaving two proximal slits 534, a distal end having a slit 536, and acentral section 532 on either side of the aperture 535. The centralsection 532 has a convex base and together with the proximal slits 534,delineates proximal wings 538. The distal edge has a slit 536, andtogether with the central section 532 delineates distal wings 540.

FIG. 43 shows the same adhesive patch 410 as shown in FIG. 37A-B, but ina planar view to more accurately display the shape and proportions. Theadhesive patch 410 has an oval aperture 415, a wide proximal end 412,and a wide distal end 414. The adhesive patch 410 has a narrowed centralsection 424 defined by concave sidewalls 420. The proximal end 412 mayhave one or more slits 416 dividing the adhesive patch 410 into proximaltabs 417. Likewise, the distal end 414 may have a slit 418 dividing theadhesive patch 410 into distal tabs 419. The proximal end 412 and thedistal end 414 attach to the suprapubic region and scrotum respectivelywhile the central section 413 lays around the penile shaft.

Another embodiment of an adhesive patch 550 is shown in FIG. 44 ; thepatch 550 is otherwise the same as the previously described embodimentshown in FIG. 43 , except that it has an aperture 551 which is circular.FIG. 45 illustrates another embodiment of an adhesive patch 550 havingan oval aperture 555, wherein the distal end 556 is provided with aplurality of slits 553, dividing the distal end 556 into distal tabs552, 554. The additional number of distal tabs promotes secure fasteningof the adhesive patch 550. FIG. 46 illustrates another embodiment of anadhesive patch 5560 having an oval aperture 561B, wherein distal end 559is provided with a plurality of slits 563 dividing said distal end 560into distal tabs 562. The shape of the distal tabs 562 illustrated inFIG. 46 are a variation of the shapes of the distal tabs of FIG. 45 ,having a more open “V” shape, for improving adhesion to (or fasteningover) the suprapubic region.

In some embodiments (for example, the urine removal device 570 of FIG.47 ), an adhesive patch 571 may be removably attached to the pouch 572.That is, the adhesive patch 571 may be connected to the pouch 572 via aninterface that may use threads, a twist-lock (¼ or ½ turn for example),an interfacing male/female flange pair 574 and 576, or any suitableinterfacing component pair (comprising first and second interfacingcomponents configured that interface with each other). The pouch 572 mayhave a corresponding interfacing member or receiving member 576 such asa flange to match a connector 574 on the adhesive patch 571. Adetachable interface of this kind allows the operator to remove thepouch for cleaning or replacement while leaving the patch 571 securedvia adhesive around the penis, which may save the operator time andeffort while preventing any discomfort to the patient that may beincurred while removing and applying the adhesive patch.

FIG. 48 illustrates an embodiment of the urine removal device 580 thatis capable of being affixed to clothing (for example, a diaper orundergarment 584 worn by a patient).

As would be apparent from FIG. 48 that this may in an embodiment beachieved by incorporating the interfacing mechanism that has beendiscussed in connection with FIG. 47 . In the embodiment illustrated inFIG. 48 the undergarment 584 to which the urine removal device 580 isintended to be affixed is provided with one of an interfacing componentpair, or any other suitable interface, while the pouch 582 may have theother of the interfacing component pair (comprising first and secondinterfacing components configured to interface with each other) whichenables the urine removal device 580 and the undergarment 584 to beremovably interfaced. While the interfacing components are hidden inFIG. 48 , they are similar to that shown in FIG. 47 , namely, the firstinterfacing component may be affixed to the article of clothing, whilethe second interfacing component may be affixed to the pouch 582. Byproviding an aperture within the interfacing component (that is affixedto the article of clothing), and by providing affixing the secondinterfacing component onto the pouch 582, in a manner that it surroundsthe aperture formed within pouch 582, the patient's penis can passthrough such aperture and the interfacing component pair and into pouch582 through the aperture provided on pouch 582. The interfacingcomponent pair of FIGS. 47 and 48 may be configured to provide a fluidtight interference between the components.

In another embodiment, as illustrated in FIG. 49 , a urine capturedevice 590 has a pouch 592 which includes one or more super-absorbentmaterials 591 (for example, a super-absorbent polymer) disposedtherewithin, which when in contact with urine 25, the super-absorbentmaterial 591 binds to form a non-liquid composition to prevent orminimize leakage or pooling of urine. It is within the scope of thisdisclosure that this super-absorbent material 591 may be included inother pouches presented herein to improve performance.

In some embodiments, urine evacuation may be improved by having oneconduit member blocked so that suction is preferentially diverted toanother conduit member. For example, FIG. 50 shows the urine removaldevice 1 previously described (also shown in FIG. 13 ) tilted sidewaysduring use; the overall orientation is indicated by the arrow depictinggravity. Since the first conduit member 18 is not exposed to much urine,if any, the conduit member 18 will suck in air which may reduce thesuction of the second conduit member 22 which is exposed to more urinedue to the gravitational settling of the liquid. A conduit system havinga valve that automatically blocks the upper conduit member (18) whileallowing the lower conduit to maintain suction may increase the efficacyof the evacuation.

Now with reference to FIG. 51 which illustrates an example of a valve600 for blocking flow in a conduit. The valve 600 comprises a section ofa main conduit member 602 for evacuating urine, a branch 604 extendingfrom the conduit member 602, and a ball 605 captive inside of the branch604. The ball 605 is constrained to move between the end 608 of thebranch and a retaining feature 606 inside of the lumen of the conduitmember 602. As shown in FIG. 51 the valve 600 is in the open positionsuch that flow is permitted through the conduit member 602.

FIG. 52A shows the valve 600 in the opposite (inverted) position whereinthe flow in the conduit member 602 is blocked. When the branch 604 issubstantially aligned with gravity, the ball 605 falls until it isstopped by the retaining feature 606, such that the ball 605 resides inthe lumen of the conduit member 602 thus blocking or partially blockingfluid (air or liquid) flow past the ball 605. One skilled in the artwould recognize that the ball 605 should be sized so that it fits intothe retaining feature 606 at least partially blocking the conduit member602 and is still free to translate back into the branch 604 when theorientation of the valve 600 changes. In embodiments a valve may beintegral to the conduit member, or it may be a modular joint, like a “T”joint that can be attached in-line in a conduit.

There are many types of tilt activated valves that may be used for thepurpose of substantially blocking one conduit member when a urinecapture device tilts such that urine pools to one side of a urineremoval device. FIGS. 52B-52C illustrate other examples of valvesaccomplishing this function are within the scope and contemplated bythis disclosure.

FIG. 52B shows another valve system 5201 having a modular design whereinfirst and second conduits 5202 and 5204 attach at a first end, and anexit conduit 270 attaches at the opposite end 5203. The valve system5201 is shown in a sideways orientation as indicated by the “gravity”arrow. The valve system 5201 comprises a first branch 5205, which housesa first ball 5206, and a retainer 5205 a to stop the first ball 5206when tilted to a certain degree, as shown. When the first ball 5206 isstopped as shown, it blocks an end aperture 5205 b in the retainer 5205a to prevent flow of fluid (liquid or air) which would otherwise flowthrough the pathway which originates at the first conduit 5202, througha side aperture 5205 c, into the first branch 5205, and through the endaperture 5205 b which leads to an exit conduit 270. In contrast, thesecond branch 5207 of the valve system 5201 has a second ball 5208 whichis disposed in the distal end 5201 of the second branch 5207 due to theforce of gravity. As such, the second branch 5207 is open, thus allowingfluid to flow from the second conduit 5204, through a side aperture 5207c, through an end aperture 5207 b and out through the exit conduit 270,which may be a suction source conduit or another segment of conduit.

Yet another valve system 5211 is shown in FIG. 52C. This system 5211comprises a pair of flap valves 5216 and 5218 that rotate under gravityand is shown in a sideways configuration indicated by the “gravity”arrow. The valve system 5211 comprises a first branch 5215 in fluidcommunication with a first conduit 5212 and a second branch 5217 influid communication with a second conduit 5214. As shown, the firstbranch 5215 has a blocked flow path and the second branch 5217 has anopen flow path to the outlet 5213 which connects to another conduit 280.The branches 5215 and 5217 comprise flap valves 5216 and 5218,respectively, that can open and close based on the orientation of thevalve system 5211 with respect to gravity. The first flap valve 5216 hasa hinge 5216 a where it attaches to the first branch 5215 and, as shown,the weight of the valve 5216 has pulled it down into a closed position.In contrast, the second flap valve 5218 has a hinge 5218 a at its basewhere it contacts the second branch 5217 and resides in the nominal oropen position as shown. Thus, in this configuration fluid may flow, asdesignated by the solid arrows (e.g., arrow 5219) from the secondconduit 5214, through the second branch 5217, out of the outlet 5213 andinto the conduit 280 that is downstream. Both valve systems 261 and 5211shown in FIG. 26 and FIG. 52C, respectively, are modular in that theymay be connected to conduits by press fitting, bonding, or any othermethod of joining plastic parts. In some examples, the valve systems maybe made integral to the conduits in a single molded part or an insertmold, for example.

FIG. 53 illustrates a conduit system 610 having a first valve 616 and asecond valve 618, located on a first conduit member 612 and a secondconduit member 614, respectively. In this embodiment, each valve issimilar to that shown in FIGS. 51 and 52 , however, the valves 616 and618 have opposing orientations (facing away from the centerline of theconduit system 610) on each conduit member 612 and 614 such that onlyone valve closes when the system 610 tilts. The second valve 618 is inan open condition such that the ball 619 captive at the end of thebranch 620 and away from the lumen of the second conduit member 614.This allows flow indicated by arrow 611 through the second conduit 614and out of the suction conduit 613. In contrast, the first valve 616 isin the closed state because the ball has fallen into the lumen of thefirst conduit member 612, thus partially or full blocking air flow andpermitting a stronger suction through the second conduit member 614 thatis exposed to urine (not shown).

Now with reference to FIG. 54 , which shows the conduit system 610 ofFIG. 53 in an upright orientation as if looking at a patient who isstanding—gravity is pointing downward. This orientation shows that thebranches 615 and 620 of the first and second valves 616 and 618,respectively, are oriented laterally and pointing somewhat downward fromeach conduit member 612 and 614, respectively. In the state shown, theconduit system 610 is open in both branches so that flow may ensue, asboth conduit members 612 and 614 are open to fluid flow as indicated bythe arrows. Thus, to accommodate both scenarios where the patient isstanding and lying in bed with the conduit system on an angle, thebranches are tilted downward and outward. One skilled in the art willrecognize that there are many types of tilt activated valves that may beused for the purpose of substantially blocking one conduit member when aurine capture device tilts such that urine pools to one side of thepouch. Other valves accomplishing this function are within the scope andcontemplated by this disclosure.

Method of Use

With respect to the general use of embodiments of this disclosure, forclarity, a reader should refer to FIGS. 1A-B, which show an embodimentof a device, FIGS. 3A-3B, which provide a depiction of an embodimentduring use on a user and along with vacuum source, FIG. 37A-37B, whichdetails an exemplar layering of an adhesive patch, and FIG. 55 , whichrepresents a flowchart of a use scenario in some embodiments. The orderof operations is for illustration only and is not meant to be limiting,as some operators may prefer an alternate sequence of steps, additionalsteps, or fewer steps. Such variations and modifications are within thescope and spirit of the inventions and embodiments contemplated herein.

Referring to FIG. 55 (and FIGS. 1A-1B, FIGS. 3A-3B, and FIGS. 37A-37B)first, a user may align the head of a penis with the aperture 43, andconcomitantly, aperture 3 (step 451), such that positioning of thedevice over the penis will introduce the penis at least partiallybetween first wall 4 and second wall 6 of the pouch 2 (step 452). Itshould be noted that in certain users, namely those with retracted orshort-shaft penile variations, may only experience the aperture 43 (ofthe adhesive patch) surrounding the penis without touching orinteracting with second wall 6. The device may subsequently be movedproximally toward the user such that adhesive patch 8 is in contact withor substantially near the root of the penis and surrounding skin (step453). The release liner 423 may be removed from the adhesive layer 421(step 454) to expose the inner surface 422 b (not shown), which issticky or tacky, and press the adhesive patch 8 against the skin adheresthe inner surface 422 b of the adhesive layer 422 such that it residesflush with the user (step 455). If required, the proximal tabs 417 anddistal tabs 419 may be maneuvered either during adhesion or afterward toassist in customizing the adhesive fit with the user (step 456). Next, adrain tube 38 may be temporarily and removably coupled with suctionsource tube 24 (step 457), after which the vacuum source 44 may beactivated (step 458). With reference to the flowchart of FIG. 55 , aspreviously noted, it would not be necessary for each step to occur inthe illustrated sequence; for example, steps 454 and 458 may beperformed at a number of earlier stages.

The devices described in embodiments herein provide for urine removaldevices that may be used by patients or other users in the proneposition, lying sideways, or sitting because the designs are effectiveat containing urine without leaking and evacuating urine quickly awayfrom the anatomy.

It should be appreciated that all combinations of the foregoing conceptsand additional concepts discussed in greater detail below (provided suchconcepts are not mutually inconsistent) are contemplated as being partof the inventive subject matter disclosed herein and may be used toachieve the benefits described herein.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

In general, any of the apparatuses and methods described herein shouldbe understood to be inclusive, but all or a sub-set of the componentsand/or steps may alternatively be exclusive, and may be expressed as“consisting of” or alternatively “consisting essentially of” the variouscomponents, steps, sub-components or sub-steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

1.-29. (canceled)
 30. A device for collecting and transporting urinecomprising: a flexible pouch having a first wall and an opposing secondwall and a substantially open space therebetween; an aperture throughthe first wall, the aperture configured to receive at least a part of apenis; a frame having a distal end inside of the pouch distal to theaperture and a proximal end outside of the pouch proximal to theproximal end of the pouch; and wherein the frame comprises a lumencapable of transporting fluid from inside of the pouch to outside of thepouch when a vacuum is applied to the lumen.
 31. (canceled)
 32. Thedevice of claim 30 wherein the frame comprises two distal elongatemembers having a pair of openings at the distal end of the pouch,wherein the distal elongate members converge to one proximal member atits proximal end.
 33. The device of claim 32 wherein the distal elongatemembers are disposed at opposing sides of a longitudinal axis of thepouch.
 34. (canceled)
 35. The device of claim 30 wherein the structuralsupport includes a flexible joint proximal to the pouch to at leastpartially isolate the pouch from motion of the proximal end of thestructural support to reduce tugging on the pouch and kinking near aninterface between the pouch and the structural support. 36.-37.(canceled)
 38. The device of claim 30 further comprising: an adhesivepatch attached to the flexible pouch, the adhesive patch configured forfastening said flexible pouch to a patient's suprapubic region. 39.(canceled)
 40. A urine removal device comprising: a flexible pouchdefining an internal compartment, the flexible pouch having a proximalend and a distal end and an aperture disposed on an external surface,wherein the aperture is capable of receiving at least a part of a penis.at least one suction conduit member affixed to the flexible pouch, eachsaid suction conduit member comprising a conduit shaft, the conduitshaft including a fluid inlet, a fluid outlet and a lumen connecting thefluid inlet to the fluid outlet, wherein: the fluid inlet is positionedwithin the internal compartment of the pouch between the aperture andthe distal end; at least a first part of the conduit shaft is positionedbetween the aperture and the distal end; and at least a second part ofthe conduit shaft is positioned between the aperture and the proximalend of the pouch.
 41. The urine removal device of claim 40, wherein thefirst part of the conduit shaft terminates within the internalcompartment at a position between the aperture and the distal end of thepouch.
 42. The urine removal device of claim 40, wherein the second partof the conduit shaft extends outside of the internal compartment andterminates at a position: between the aperture and the proximal end ofthe pouch; or at a position beyond the proximal end of the pouch in adirection that is opposed to the distal end.
 43. (canceled)
 44. Theurine removal device of claim 40, wherein the at least one suctionconduit member comprises one or more rigid or partially rigid conduitshafts configured to form a frame that separates two opposing innerwalls of the pouch.
 45. The urine removal device of claim 40, whereinthe at least one suction conduit member comprises one or more conduitshafts having a first fluid inlet within the internal compartment, and asecond fluid inlet within the internal compartment, wherein the firstfluid inlet and second fluid inlet are positioned on opposite sides ofthe pouch.
 46. The urine removal device of claim 45, wherein the firstfluid inlet and the second fluid inlet within the internal compartment,wherein the first fluid inlet and second fluid inlet are positioned onopposite sides of a longitudinal axis connecting the proximal and distalends of the pouch.
 47. The urine removal device of claim 40, comprisinga fold resistant feature on at least one suction conduit member, whereinthe fold resistant feature is configured to resist collapse of a lumendefined by said suction conduit member. 48.-51. (canceled)
 52. The urineremoval device of claim 45, wherein a distance between the first fluidinlet and the second fluid inlet is greater than a width of theaperture. 53.-57. (canceled)
 58. A device for collecting andtransporting urine comprising: a flexible pouch having an apertureconfigured to receive at least a part of a penis, the flexible pouchhaving an interior surface defined by at least a first inner surface andan opposing second inner surface; at least one suction conduit memberaffixed to the flexible pouch, the conduit including a fluid inletinside of the pouch near a distal end of the pouch and a fluid outletoutside of the pouch; and a plurality of flow directors disposed on atleast a portion of the first inner surface of the pouch such that whenthe first inner surface and second inner surfaces are drawn together byvacuum suction, channels are created therebetween.
 59. The device ofclaim 58 wherein the flow directors comprise one of grooves or ridgesand the channels have a depth of less than 1 mm.
 60. The device of claim59 wherein the grooves are recessed into the first inner surface of thepouch.
 61. The device of claim 59 wherein the flow directors aresubstantially oriented parallel to an axis from a proximal end to adistal end of the pouch.
 62. The device of claim 58 wherein the flowdirectors are formed by a plurality of elongate fibers spaced apart overat least a portion of the first inner surface.
 63. (canceled)
 64. Thedevice of claim 58 further comprising: a plurality of flow directorsdisposed on at least a portion of the second inner surface of the pouch.65.-66. (canceled)
 67. The urine removal device of claim 40, wherein: atleast one suction conduit member comprises a first conduit shaftextending along one side of the periphery of the internal compartment ofthe flexible pouch and ending in a first fluid inlet at a distal endregion of the flexible pouch, and a second conduit shaft extending alongan Filing Date: Herewith opposite side of the periphery of the internalcompartment of the flexible pouch and ending in a second fluid inlet ata distal end region of the flexible pouch; a first gravity activatedvalve is in fluid communication with the first conduit shaft, whereinthe first gravity activated valve is configured to close when the firstconduit shaft is positioned above the second conduit shaft; and a secondgravity activated valve is in fluid communication with the secondsuction conduit, wherein the second gravity activated valve isconfigured to close when the second conduit shaft is positioned abovethe first conduit shaft.